ABSTRACT

Nanoemulsions appeared as a novel drug delivery system which allows controlled or sustained release of drug and biological active ingredients. Nanoemulsion is a dispersion consisting of oil, surfactant and an aqueous phase, which is an isotropically clear and thermo-dynamically or kinetically stable liquid solution, usually with droplet diameter within the range of 1-100 nm. This review gives the idea about the nanoemulsions system and provides brief information about the method of preparation and evaluation of nanoemulsion as well as various pharmaceutical applications of nanoemulsions in drug delivery including parenteral and pulmonary drug delivery, cosmetics, cancer therapy, vaccine delivery, formulations for improved oral delivery of poorly soluble drug and in cell culture technology.

Keywords: Nanoemulsion, Method of preparation, Pharmaceutical applications

ABSTRACT

Tuberculosis is a bacterial infection, which is the dominant cause of death all over the world. It is the chronic infectious disease caused by the tubercle bacillus. It is regarded as oldest disease. Tuberculosis is the infection occurs by inhaling the droplet nuclei containing Mycobacterium tuberculosis organisms by susceptible person. New methods have been evolved in diagnosing, treatment and prevention. The disease remains as an important public health problem in developing countries. Extra pulmonary TB became more common with the advent of infection with human immunodeficiency virus and by the increase in the number of organ transplantation, which also leads to immunosuppression of thousand of persons. Urogenital TB represents 27% of extrapulmonary cases. Renal involvement in TB can be part of a disseminated infection or a localized genitourinary disease. Renal involvement by TB infection is underdiagnosed in most health care centers. Most patients with renal TB have sterile pyuria, which can be accompanied by microscopic hematuria. The diagnosis of urinary tract TB is based on the finding of pyuria in the absence of common bacterial infection. The first choice drugs include isoniazide, rifampicin, pirazinamide, ethambutol, and streptomycin. Awareness of renal TB is urgently needed by physicians for suspecting this disease in patients with unexplained urinary tract abnormalities, mainly in those with any immunosuppression and those coming from TB-endemic areas.

Keywords: Tuberculosis, Micobacterium Tuberculosis, Discover, Symptoms, Type, Diagnosis, Treatment.

ABSTRACT

Resealed erythrocytes have been evaluated in thousands of drug administration in humans proving safety and efficacy of the treatments. Carrier erythrocytes, resealed erythrocytes loaded by a drug or other therapeutic agents, have been exploited extensively in recent years for both temporally and spatially controlled delivery of a wide variety of drugs and other bioactive agents owing to their remarkable degree of biocompatibility, biodegradability and a series of other potential advantages. Biopharmaceuticals, therapeutically significant peptides and proteins, nucleic acid-based Biologicals, antigens and vaccines, are among the recently focused pharmaceuticals for being delivered using carrier erythrocytes. In this review article, the potential applications of erythrocytes in drug delivery have been reviewed with a particular stress on the studies and laboratory experiences on successful erythrocyte loading and characterization of the different classes of biopharmaceuticals.

Keywords: Resealed Erythrocytes, Morphology of erythrosites, Characterization of Resealed Erythrocytes, Storage of Erythrocytes

ABSTRACT

According  to the model proposed by James Watson and  Francis Crick of DNA  molecule consists of two  long  strands coiled  around a common ,imaginary, central axis to form double helix .DNA is genetic material of living organism and is located in the chromosomes of each cell. If every organism most produce copies of itself in order to pass on genetic information to its young before it dies. DNA replication results is one DNA molecule becoming two daughter molecules each an exact copy of the original molecule. Each new DNA molecule consist of one old strand and one new strand .If the replication method were semi-conservative ,one round  of replication would yield  to DNA  molecule that each contain one strand of parental DNA  and one strand of new DNA . After replication each DNA molecule has one old and the other new strand. It shows that 50%part of the mother molecule is retained or conserver while remaining 50% part is newly constructed. Hence the process is referred to as semi-conservative replication.   DNA – polymerase catalyses polymerization only in one direction that is 3'-5'.  Consequently one stand replication is continuous, while on the other stand it is discontinuous.

Keyword:  James Watson and Francis Crick model of DNA, Semi-conservative replication.

ABSTRACT

In the pharmaceutical industry today, there are some examples of the use of quality risk management but, they do not represent the full contributions that risk management has to offer. Quality risk assessment is a process of identification of hazards, analysis and evaluation of the risks associated with exposure to those hazards. Risk assessment is a main part of quality risk management process. The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the safety of the patient. For any pharmaceutical organization, quality risk management should aim at raising the level of protection for the patient, by reduction of the risk to which that patient is exposed at the time he/she receives a drug product. In the present seminar report all the aspects regarding quality, quality risk assessment and risk management are covered in great detail.

Keywords: quality, risk management, risk assessment, hazards, analysis, evaluation of risks

ABSTRACT

The development of nanoscience and its various technologies has tremendously helped to develop many dosage forms for various complicated diseases. This is a unique technology for the drug delivery containing micro porous beads loaded with drug material inside them. The nano sponge like materials are produced in order to improve the targeting characteristic along with a comfort to diminish the treats of ailments by using  mostly available drugs and their by helping to prevent most of the drug-protein degradation in the body. The development of these tiny discrete, porous and a colloidal mesh structure called as ‘nanosponges’ are preferable for topical, oral, inhalational deliveries. They are very small micronized structures of less than 1 µm. They act like a controlled and targeted material with an ease formulation and have a maximum stability. These micro molecules are synthesized from water soluble and bio erodible polymers. This tiny structure can stick, adhered or localizes to specific target receptors to produce controlled response. These materials must be focused in future and is a well promising material to be used in pharmaceutical sector. Their performance to entrap drugs or even to become complex for a desired release onto the site of action within a specific time without alteration in temperature is an advantage. In this review a brief summary of sponges with the introduction, advantages, disadvantages, preparation, loading, evaluation, and conclusion are discussed with a motto to include them in future drug developments.

Keywords: Nanosponges, nanotechnology, synthesis, preparation.

ABSTRACT

HPLC is the dominant separation technique in modern pharmaceutical and biomedical analysis because it results in highly efficient separations and in most cases provides high detection sensitivity. Most of the drugs in multi component dosage forms can be analyzed by HPLC method because of the several advantages like rapidity, specificity, accuracy, precision and ease of automation in this method. HPLC methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. It is the most versatile, safest, dependable and fastest chromatographic technique for the quality control of drug components. This article was prepared with an aim to review different aspects of HPLC, such as principle, types, instrumentation, validation of HPLC and application. 

Keywords: High performance liquid chromatography, instrumentation, validation of HPLC, applications.

ABSTRACT

Naringenin is a flavonoid which has been used for its wide pharmacological action from ancient years including as antidiabetic agent. Naringenin is a lipophilic drug (BCS-II) and have low water solubility (1 in 1000), bioavailability (<25%) and have short half-life (t_1/2 =1.3 -2.2h). Nanocrystals is an approach to increase the therapeutic performance of poorly water soluble drugs. The purpose of the present study was to prepare nanocrystalss of naringenin to improve bioavailability and increase therapeutic efficacy. Nanocrystalss of naringenin were prepared by antisolvent precipitation method. The stabilizers used to improve aggregation and increase the solubility. Nanocrystals were characterized for particle size, morphology, release profile and thermal analysis.

Keywords: Naringenin, Nanocrystals, Bioavailability, Solubility, antisolvent precipitation.

ABSTRACT

A Stability indicating isocratic liquid chromatographic method with UV detection at 255 nm is described for simultaneous determination of sofosbuvir and velpatasvir  in its bulk and tablet dosage form. Chromatographic separation of two drugs was achieved on a YMC column (4.6×15mm,5 ) using a mobile phase consisting of a binary mixture of acetonitrile and 0.025M KH₂PO₄  adjusted to pH3..0 with orthophosphoric acid in ratio 50:50. The developed Liquid Chromatographic method offers symmetric peak shape, good resolution and reasonable retention time for both drugs. Linearity, accuracy and precision were found to be acceptable over the concentration range of 50-250 µg/ml for velpatasvir and 200-1000µg/ml for sofosbuvir and R² found to be 0.999. Accuracy was measured via recovery studies and found to be acceptable, and the percentage recoveries were found in the range of 97-103%.Method precision results obtained are 0.1%RSD for sofosbuvir and 0.8%RSD for velpatasvir. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic and thermal degradation. The proposed method was successfully validated and applied for the quantitative estimation of these drugs in both bulk and tablet dosage forms. The LC method can be used for the quality control of formulated products containing sofosbuvir and velpatasvir.

Keywords: liquid chromatography; sofosbuvir, velpatasvir, forced degradation studies.

ABSTRACT

A simple, specific, accurate, precise and sensitive RP- HPLC method has been developed for the rapid estimation of Alogliptin in bulk and its formulations. The chromatographic separation was carried on Phenomenex Gemini-NX-5 µm C18(2) 110A, LC Column 250 x 4.6 mm, using Acetonitrile:1-octasulphonoic acid (0.005mM) at pH-5 [60:40] (v/v) as mobile phase, at a flow rate of 1.0 ml/min.  The detection was carried out at 220 nm and drug eluted with a retention time of 3.48 min. Beer’s law was obeyed in the concentration range of 2-10?g/ml with correlation coefficient 0.9995. The method has been validated according to ICH guidelines for specificity, linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. The method was found to be specific, accurate, and precise, robust, rugged and sensitive. The developed method was good linearity, novel, rapid for the estimation of Alogliptin in bulk and tablets dosage form. Thus it can be employed for the routine analysis.

Keywords: Alogliptin, RP-HPLC, Validation.

ABSTRACT

The aim of the current study was to formulate and characterize oral floating alginate microspheres of Rebamipide to sustain the gastric residence time and to target gastritis. The floating alginate microspheres were prepared by ionotropic gelation technique. Sodium alginate was used as polymer, sodium bicarbonate as gas generating agent, calcium chloride as cross-linking agent, HPMC K4, HPMC K15 as rate retarding agent. Microspheres were characterized for the Micromeretic properties, entrapment efficiency, buoyancy test, SEM analysis, FTIR, and in vitro release studies. The release studies were carried out in 0.1N HCl and the results were applied to various kinetic models.  Among the total 14 formulations F12 was optimized. The % yield of F12 formulation was found to be 93.73%. On the basis of optical microscopy, the particle size was 79.45±0.09µm. The % buoyancy, % entrapment efficiency and swelling index of F12 formulation was 94.2%, 95.5% and 96.16, respectively. The Cumulative % drug release of F12 formulation was 96.12±0.22% in 12h when compared with marketed product 95.15±0.23 in 1h.  SEM studies showed the particles were in spherical shape. Based on obtained results, floating alginate microspheres were of good candidate for targeting to GIT in the efficient management of gastritis.

Keywords: Rebamipide, Floating microspheres, gastritis, buoyancy, SEM studies,

ABSTRACT:

Floating microspheres of Tolcapone was prepared by ionotropic gelation method with an aim of increasing the gastric residence time and for controlled release using different polymers like HPMC K4M and HPMC K15M as rate retarding agent in concept to optimize the formulation. The FTIR studies indicated no significant interaction observed between drug and excipients. The F12 formulation showed the excellent flow properties. % yield, % entrapment efficiency and swelling index of optimized formulation was found to be 98.45%, 98.02% and 98.50%, respectively. The %buoyancy was excellent with approximately 98.42% of the microspheres floating upto 24h. The Cumulative % drug released from F12 microspheres was found to be 98.26±5.05% with in 12h and compared with the marketed product 91.25±5.00%. The optimized formulation F12 best fitted into zero order and Higuchi kinetics indicating diffusion controlled drug release pattern. SEM studies showed spherical shape and revealed the presence of pores on the floating microspheres surface which was responsible for floating ability. From stability studies optimized microspheres were stable at for 6 months. The F12 formulation showed the better results with HPMC K15M compared with HPMC K4M as rate retarding polymer. These results indicated that the Tolcapone loaded microspheres could potentially be exploited as a delivery system with controlled drug release in the effective management of Parkinson’s disease.

Keywords: Floating microspheres, Tolcapone, HPMC, %buoyancy, Release order kinetics.

ABSTRACT

Enrofloxacin (EFX) is a third generation Fluoroquinolone with a broad spectrum antibacterial activity. Enrofloxacin hydrochloride is 1-cyclopropyl-7-(4-ethylpiperazin-1-yl)-6-fluoro-4-oxo-1, 4-dihydroquinoline-3-carboxylic acid. A Sensitive, simple and rapid reverse phase high performance liquid chromatographic method was developed for the determination of Enrofloxacin (EFX) in tablet dosage form. The chromatographic separation was performed on a Kromasil C-18 column (250mm x 4.6 mm x 5µ) in isocratic mode using phosphate buffer pH 3:Methanol (40:60 v/v), pH adjusted to 3.0 using orthophosphoric acid as mobile phase at a flow rate of 1.0 ml/min with column temperature 30 ^OC. The quantification was performed at 280 nm. The method showed good linearity over the concentration range of 5-25 µg/ml with correlation coefficient r² 0.9996. LOD and LOQ was found to be 1.0 and 3.0. The developed RP HPLC method was applied to EFX in tablet dosage form and results were found to be in agreement with the label claim.

Keywords: Enrofloxacin, RP-HPLC, Fluoroquinolone, ICH guideline (Q2R1)

ABSTRACT

A sensitive and rapid HPLC method developed and validated for the determination of potential genotoxic impurity namely m-aminobenzoic acid at trace level in Ertapenem monosodium by applying the concept of threshold of toxicological concern (TTC). The HPLC method was developed and optimized on Inertsil ODS-3V, 250 mm × 4.6 mm, 5mm column with oven temperature maintaining at 40°C. 0.02M Sodium Phosphate buffer pH 2.5 was chosen as mobile phase A and methanol was selected as mobile phase B in gradient reverse phase mode. Chromatographic parameters i.e flow rate: 1.0 ml/min, wavelength detection: 220 nm, injection volume: 10µl and run time: 20 min were applied in this methodology. Based on validation data, the method is found to be specific, sensitive, accurate and precise. The established limits of Limit of detection and Limit of quantification for this impurity are found to be 3.9 µg/g and 11.9 µg/g respectively.  The average recovery obtained was 99.8% at four levels in twelve determinations for m-aminobenzoic acid in Ertapenem monosodium drug substance. This method can be used as good quality control tool for quantization of m-aminobenzoic acid at low level. The experimental results are discussed in detail in this research paper.

Keywords:  Ertapenem monosodium, m-aminobenzoic acid, Genotoxicity, Validation &   HPLC.

ABSTRACT

A stable, simple, accurate, precise, robust and highly selective Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed and validated using ritonavir. Chromatographic separation was achieved using cyber labs, LC 100 separation module, Agilent C18 column at temperature 30°C. Flow rate selected was 1ml/min. Both drugs are identified with UV detector at 256nm. Mobile phase employed was Methanol: Water (50:50), which resulted best   sensitivity. Developed method was validated in terms of linearity, range (25-150µg/ml), precession (correlation coefficient is less than 0.999), robustness, accuracy(recovery was 101.96%) and  under stress conditions drug degradation was less than 10%.The validation of proposed stability indicating method was verified by recovery studies and can be applicable in routine pharmaceutical analysis.

Keywords: RP-HPLC, methanol, HPLC grade water, stress studies, stability, method development, validation

ABSTRACT

AIM :Febrile  seizure  is  the  one  of  the  most  common  convulsive  disorders, mainly  occur  following  high  fever  without  any  evidence  of  underlying  health  issues, typically   in  the  children  of  age  of  upto  6  years. The  aim  of  this  study  was  to  assess the  relationship  between  variable  causative  factor  involved  in  the  incidence  of  febrile  convulsions between the  children  referred  to  Cosmopolitan Hospital, Thiruvananthapuram, Kerala (India). This  was  a hospital  based  prospective  observational  study. The  main  purpose  of  this  study  was  to identify  the  relationship  between  variable  risk  factors  associated with febrile  convulsion  in  children. The  children  of  age  upto  6 years  were  studied  to  assess  the  relationship  between  the  types of seizure ,gender ,electrolytes  and  variable  disease  conditions  which  leads  to  the  development  of  convulsive  event  in  children. The age and febrile seizure has a correlation that the children below 3 years is more hospitalized with febrile seizure. Viral fever associated febrile seizure shows more prevalence. Type of seizure and gender do not have any positive correlation in this study. Lab data provide significant positive correlation with the incidence febrile seizure. Pregnancy related complications and antenatal and natel complications also shows a significant relationship to the febrile seizure. Decreased breast feeding in the children also leads to the events of febrile seizure. family history of febrile seizure also provide a major relationship with febrile convu. Risk factor such as age, body temperature, family history, breastfeeding, low birth weight, cesarean, lab data’s that are involved in the development of febrile seizure were identified.

Keywords: Febrile convulsion, gender, viral fever, electrolytes

ABSTRACT

Vitamin C is an essential nutrient needed for maintaining for human health. Strawberry juice is easily damaged in transit due to temperature fluctuations and in the presence of oxygen in an oxidation reaction that may significantly reduce shelf life. In this way, one week  stability studies of freshly prepared  juice of strawberry  and the marketed formulation of strawberry (juicy jelly) was conducted and the amount of ascorbic acid degraded ,juice kept at room temperature as well as 0-6°C and degraded amount was found by iodine titration method. The degradation of vitamin C was found in freshly prepared juice and marketed formulation that was kept at room temperature. Furthermore, it showed fast decrease of shelf life for freshly prepared juice kept at room temperature compared to the freshly prepared juice kept at refrigerator temperature and marketed formulation. The degradation amount of vitamin c in freshly prepared juice was found to be more compared to the marketed formulation. For freshly prepared juice at room temperature vitamin C degradation rate ranges from 240.677mgL to166.10mgL .At refrigerator condition the vitamin C content ranges from 240.67mgL to 176.27mgL. For marketed formulation kept at room temperature the vitamin C content ranges from 50.8mg/L to 41.2mg/L. At refrigerator condition the vitamin C content ranges from 50.8mg/Lto48.6mg/L.

Keywords: Vitamin C (Ascorbic acid), Strawberry juice, Marketed Formulation (juicy jelly), Iodine solution, Starch solution, Room Temperature, Refrigerator.

ABSTRACT

The present study was undertaken to evaluate Anxiolytic activity of methanolic extract of caltropis gigantea flowers. Of caltropis gigantea (200,400 mg/kg) was studied. Diazepam used as a standard drug (2mg/kg), by using EPM Model. The diazepam and all the doses of extract had showed significant Anxiolytic activity the finding this experimental animal study indicates that caltropis gigantea posses Anxiolytic activity

Keywords: Anxiolytic activity Elevated plus maze model, diazepam, caltropis gigantea flowers

ABSTRACT

Albendazole (ALB), chemically known as methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate is widely used as an anthelmintic having a wide spectrum of activity. Numerous numbers of analytical methods are there for the simultaneous estimation of bulk and in formulation, such as spectrophotometry and liquid chromatography. As the UV spectrophotometric method is rapid, simple, accurate and economical, the method has been developed for the assay of the albendazole in pharmaceutical formulation. The wavelengths selected for the method were at 291 nm. The results of analysis have been validated by recovery studies as per ICH guidelines. The developed method was rapid, simple, accurate and economical and it can be used for routine quality control analysis. It showed absorption maxima at 291 nm in analytical grade DMF. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity.

Keywords: Albendazole, UV spectrophotometer, Method Development, Method Validation, ICH Guidelines.

ABSTRACT

A simple and reproducible method was developed for carbimazole by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Carbimazole was separated on C₁₈ column [4.6x250mm, particle size 5μm] at the UV detection of 291nm. Methanol and OPA (0.1%) was used as a mobile phase with various ratios and flow rates, eventually 80:20 v/v Methanol and OPA (0.1%) was being set with the flow rate of 0.7mL/min. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked, further the limit of detection and limit of quantification of carbimazole concentrations were found to be within the limits. Recovery and assay studies of carbimazole were within 99 to 102% indicating that the proposed method can be adoptable for quality control analysis of carbimazole.

Keywords: Carbimazole, HPLC, Methanol, Ortho phosphoric acid (OPA).

ABSTRACT

The estimation of Piperaquinen tetraphosphate and Dihydroartemisinin was done by RP-HPLC. The Phosphate buffer was pH 4.6 and the mobile phase was optimized which consists of MEOH: Phosphate buffer mixed in the ratio of 70:30 % v/ v. A Symmetry C18 (4.6 x 150mm, 5mm, Make X   Terra) column used as stationary phase. The detection was carried out using UV detector at 273 nm. The solutions were chromatographed at a constant flow rate of 1.0 ml/min. the linearity range of Piperaquinen tetraphosphate  and Di hydro artemisinin were found to be from 25-125 mg/ml. Linear regression coefficient was not more than 0.999.The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-102% of Piperaquinen tetraphosphate and Di hydro artemisinin LOD and LOQ was found to be within limit. The proposed method is precise, simple and accurate to determine the amount of Piperaquinen tetraphosphate and Di hydro artemisinin in formulation. High percentage of recovery shows that the method is free from the interference of excipients used in the formulation. So the method can be useful in the routine quality control of these drugs.

Keywords: Symmetry C18, Piperaquinen Tetraphosphate, Dihydroartemisinin, RP-HPLC.

ABSTRACT

Species of the genus Cordial, Boraginaceous, are widely studied with regard to the formulation of herbal aqueous gel with using guava leaves extract. Herbal medicines is still the mainstay of about 75-80% of the world’s population, mainly in developing countries, for primary health care because of better compatibility with human body, cultural acceptability and lesser side effects. They are found principally in tropical and subtropical regions of the India, American and African continents, where they occur in various countries. The objectives of present investigation were to formulate and evaluate herbal gel for mouth ulcer treatment of dried powered of Cordial. All species of the genus Cordial, Boraginaceous, are widely studied with regard to the various Cordial dichotomy, guava leaves and Carbopol 934, Propylene glycol as a gel base. Formulations were evaluated for various parameters like physical appearance, pH, homogeneity, spreadability, viscosity, extrudability. The formulated gel was transparent, homogeneous and pH ranges from 7 to 7.5. Formulation showed acceptable rheological behavior with applicable spreadability and extrudability properties. Present herbal formulation was developing with very safe with good stability and effective over to synthetic formulations for the treatment of mouth ulcer. This research work give to information reported in this work contributes scientifically to recognizing the importance of the genus Cordial and guava as a target in the search for new biotechnological investments and herbal formulation.

Keywords: Cordial, herbal formulation, guava, herbal gel.

ABSTRACT

The aim of present research work is to formulate and evaluate Oral dispersible tablets of frovatriptan using various diluents and superdisintegrants and to optimize the formulation. Frovatriptan is a triptan drug  used for the treatment of migraine headaches. The drug excipient compatibility study was done and  no interactions were found, DSC & XRD studies were carried out. The tablets were formulated by direct compression method using Spray dried lactose, Manito, Microcrystalline cellulose (MCC), Starch as diluents and Crospovidone, Cross-Carmel lose sodium, Sodium starch glycol ate as superdisintegrants. The pre-compression parameters like bulk density, tapped density, Carr’s Index, Haunters ratio and angle of repose were determined and all the formulations were found to be within IP limits. The post compression parameters like the hardness, thickness, friability, weight variation, and disintegrating time, wetting time, water absorption ratio and drug content for all the formulations were carried out and results were found to be as per USP limits. In-vitro drug release and kinetics studies were carried out for all the formulations, of those the formulation F₃₃ containing Cross providing (5%) and mannitol as diluent, has shown better release and follows first order kinetics. The formulations were optimized by 2² factorial design and the ANOVA study was carried out and normal plot, half normal plot and overlay plot were plotted. The tablets were stored at 40±2ËšC/75 ± 5% RH for three months to assess the stability of optimized formulation.

Keywords: Frovatriptan, Crospovidone, Crosscarmellosesodium, Sodium starch glycolate, MCC, Spray dried lactose, starch, Magnesium stearate, Talc, Aerosil and aspartame.

ABSTRACT

Edoxaban Tosylate Monohydrate (EXN) is oral anticoagulant drug indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Sensitive and reproducible UV- Visible spectrophotometric method has been developed and validated for the estimation of Edoxaban Tosylate Monohydrate in its synthetic mixture. Methanol was used as a solvent. Developed method has been validated for linearity range, precision, accuracy, limit of detection, and limit of quantification as per ICH Q2(R1) guidelines. The method was found to be linear in the range of 5-25 μg/mL at λ_max 289 nm and the regression coefficient value was found to be 0.9999. For Edoxaban LOD and LOQ values were found to be 0.654 μg/mL and 1.982 μg/mL. The method was successfully applied for estimation of Edoxaban Tosylate Monohydrate in its synthetic mixture and results were found to be in good agreement with the amount of Edoxaban Tosylate Monohydrate present in synthetic mixture.

Keywords: Edoxaban Tosylate Monohydrate, UV-visible Spectrophotometric method, Validation