ABSTRACT

We developed a straightforward, precise method for the simultaneous estimation of Ivacaftor, Elexacaftor and Tezacaftor in both bulk and tablet dosage forms. The chromatography analysis was performed using a Discovery C18 column measuring 150 x 4.6 mm with a 5µm particle size. The mobile phase, composed of Acetonitrile: Methanol: 0.1% OPA (10:35:55 v/v) was pumped at a flow rate of 0.9 ml/min, with the temperature maintained at 28°C. The optimized wavelength for detecting 3 drugs was set at 278.0 nm. Retention times were measured at 2.537 min, 2.089 min, and 3.090 min, respectively. The method precision showed low %RSD values, with 0.4 for Ivacaftor, 0.3 for Elexacaftor and 0.4 for Tezacaftor. Recovery percentages were determined as 99.79% for Ivacaftor, 99.72% for Elexacaftor and 100.05% for Tezacaftor. Furthermore, the LOD and LOQ values derived from the regression equations for  Ivacaftor, Elexacaftor and Tezacaftor i.e  y = 22674x + 2799.3, y = 21285x + 4513.2 and y = 21548x + 869.63  were found to be 0.06 ppm and 0.22 ppm, 0.18 ppm and 0.19 ppm , 0.07 ppm and 0.57 ppm  respectively. With reduced retention times, this method offers simplicity and cost-effectiveness, making it suitable for routine quality control testing.

Keywords: Tezacaftor, Ivacaftor, Elexacaftor, RP-HPLC

ABSTRACT

Plant drugs have a long history in both traditional and modern societies as crude drugs. The plant drugs have been extensively practiced as traditional medicine since centuries by peoples of almost all countries of the world. The medicinal plants are considered to be the almost exclusive source of primary health care as well as a source of pharmacological active compounds for 80 % of the world’s population, herbal medicines have been proven effective in common as well as rare diseases. Bacopa monnieri belongs to the family Scrophulariaceae is perennial, creeping herb, origin to wetlands of southern and eastern India, Australia, Europe, Asia, north and South America. The major therapeutic chemical constituents of this plant identified through various researches are the Triterpenoids, Saponins, Bacoside, Flavonoids and Glycosides. Bacoside A has been recognized as the chief component responsible for therapeutic effects. The plant is used in traditional Ayurvedic treatment for a range of CNS applications, being considered as a memory tonic. It has been found to possess various CNS actions including nootropic, antidepressant and anxiolytic action. It is also considered to be an important adaptogen. This review shall cover pharmacological properties, chemical constituents and scientific researches supporting not only traditional use of Ayurvedic claims but also other physiological conditions such as anti-inflammatory, cardio tonic and other pharmacological effects of B. monnieri extracts.

Keywords: Pharmacological activities, Scrophulariaceae, Bacopa monnieri, Traditional uses, Phytomedicines.

ABSTRACT

Unwanted materials that coexist with active pharmaceutical ingredients (APIs), surface during formulation, or become apparent after the formulation and API have run out are known as pharmaceutical impurities. The therapeutic properties of generic drugs may be affected, even in minute quantities, by the creation of these chemical pollutants. The pharmaceutical business is currently facing significant issues with impurity control. Researchers from the International Conference on Harmonization (ICH) have worked to manage pollutants. This review describes various impurity types, sources, and degrading transcription factors using specific examples.

Keywords: Impurities, Formulation, efficacy, degradation.

ABSTRACT

A straightforward and accurate method was devised for simultaneously determining Drospirenone and Estetrol in tablet dosage form. The chromatogram was generated using a Kromosil C18 column (150 x 4.6 mm, 5.0 mm), with a mobile phase consisting of Buffer 0.01N KH2PO4: Methanol in an 80:20 ratio, flowing through the column at a rate of 1.0 ml/min. This method utilized OPA as the buffer, and the temperature was maintained at 30°C. The optimized wavelength for detection was set at 263.0 nm. The retention times for Drospirenone and Estetrol were determined to be 2.597 min and 2.1336 min, respectively, with %RSD values of 0.4 for both compounds. The %Recovery was calculated as 100.25% for Drospirenone and 100.09% for Estetrol. The LOD and LOQ values were obtained from the regression equations of Drospirenone and Estetrol, resulting in 0.01 and 0.02 for LOD, and 0.08 and 0.25 for LOQ, respectively. The regression equations for Drospirenone were found to be y = 361228x + 6065.6, and for Estetrol, y = 341114x + 46689. The method exhibited reduced retention times and overall run time, indicating its simplicity and cost-effectiveness. This makes it suitable for routine quality control testing in various industries.

Keywords: Drospirenone, Estetrol, RP-HPLC, Validation.

ABSTRACT

Herbal medicinal plants are the gift of nature to the human beings. The present review is an effort to give a detail literature survey and discovering the hidden Marvels of Commiphora wightii also its remarkable health benefits in human beings. Worldwide Commiphora wightii is also known as Guggul is known for its anti-inflammatory property. Along with these it has many pharmacological activities like in the treatment of Rhematoid arthritis, fibrinolysis, weight management, Cardioprotective action, thyroid function regulation, antioxidant support and in metastatis Inhibition. It contains various chemical constituents like guggulsterones, guggulipid, commiphoric acid, Monoterpenoids, guggultetrols, Steroids, flavonoids, diterpenoids, sesquiterpenoids, triterpenes, lignans and various amino acids which contribute to various therapeutic property.

Keywords: Chemical constituents, Commiphora wightii, Guggul, Health benefits, Pharmacological activities.

ABSTRACT

The intricate structures of the eye's posterior segment pose significant challenges for effective drug delivery in the treatment of various diseases. Current modalities, such as topical and intraocular medications, often face barriers that limit their penetration, residence time, and bioavailability. This necessitates frequent dosing, impacting patient compliance and quality of life. Suprachoroidal injection emerges as a novel and promising approach for targeted drug delivery to the posterior segment. The suprachoroidal space, situated between the sclera and choroid, provides a minimally invasive route for medication delivery, offering advantages like higher drug concentrations, increased bioavailability, and prolonged action. This method also mitigates the risk of adverse events associated with other routes, particularly corticosteroid-related complications. This review discusses the potential of suprachoroidal injection, highlighting its benefits in overcoming anatomical barriers and improving therapeutic outcomes. However, further research is crucial to address existing challenges, including technological advancements, injection techniques, and considerations of cost and accessibility. Exploring synergies with biotech products, gene therapies, and cell-based treatments can pave the way for personalized and effective strategies in managing posterior segment eye diseases.

Keywords: Suprachoroidal injection, Controlled drug release, Retina, Posterior segment diseases, Ocular drug bioavailability, Ocular diseases

ABSTRACT

HLA-B27 test is generally positive in spondyloarthritis (SpA) and ankylosing spondylitis (AS). Several anomalous laboratory test results are frequently found in HLA-B27-positive patients. In this study, we intended to evaluate two groups of HLA-B27 positive patients- one group belonging to the 13-40 years age group and another group belonging to the 41-71 years age group. The rationale of this partition was based on the age when AS first emerged and the age when the disease was set up for quite a few years respectively. We anticipate alterations of several familiar laboratory test outcomes between these two groups. After our analysis, we found that in the upper age group, ESR and uric acid are significantly decreased, while SGPT, creatinine, and HbA1C are significantly increased. Other values like ct value in PCR, RA seropositivity, and TC of WBC are decreased a bit in the higher age group; haemoglobin and CRP also marginally increased in this set which are not statistically significant. The plausible explanations behind these changes are discussed.

Keywords: HLA-B27 test, spondyloarthritis, ankylosing spondylitis, PCR, ESR, uric acid, SGPT, creatinine, HbA1C.

ABSTRACT

A simple, precise, and accurate method was developed for the simultaneous estimation of Nivolumab (NVM) and Cabozantinib (CBZ) in tablet dosage form.  The chromatogram was analyzed through a Phenomenex C18 150 mm (4.6 x 150 mm, 5 m) for chromatogram processing. A mobile phase containing formic acid: methanol (50:50) was pumped through the column at a spurge flow of 1.0 mL/min.  The column temperature was upheld at 30°C.  The quantification was done at 260.0 nm.  The elution time of NVM and CBZ was found to be 2.243 min and 2.953 min, respectively. The validation for the developed method was performed and all the parameters were found within the specified limits. The standard curve results represent a correlation coefficient of more than 0.999.  The %RSD of NVM and CBZ were found to be 0.9 and 0.7, respectively.  % Recovery was achieved as 99.88% and 99.66% for NVB and CBZ, respectively. The NVM and CBZ regression equations yielded LOD and LOQ values of 0.63, 1.91, and 0.08, 0.24 respectively. The equation of Nivolumab y is 39306x + 12173 while the Cabozantinib y is 34894x + 1139.7. With all the parameters under the criteria, the developed method for the simultaneous estimation of Nivolumab and Cabozantinib can be successfully applied for regular quality control approaches.

Keywords: Nivolumab, Cabozantinib, Method Development, RP-HPLC, Validation

ABSTRACT

This study presents the analytical assay method development and validation of Itraconazole in an ointment dosage formulation by using reverse phase HPLC. The assay method development was carried out by using C18 column. In the beginning, the study was carried on Itraconazole API by taking USP method as a reference. By changing few chromatographic parameters, a symmetrical peak and a satisfactory result could able to achieve. Changes done as per USP chapter “allowable adjustment to United States Pharmacopeia method”.  The aim was to achieve an advanced chromatographic conditions on HPLC system with C18 column (150 × 4.6 mm, 5µm particle size) using mobile phase composed of acetonitrile and neutral buffer. The separation was achieved at different gradient flows for alternative methods.  The ideal wavelength was calibrated by using PDA detector and the same wavelength was used for UV- visible detector. The assay method developed was also validated with full agreement with present regulatory guidelines by applying well developed analytical method validation techniques and means which includes the parameters such as linearity, accuracy, method precision, specificity with force degradation, robustness, solution stability, system suitability. The method shows linearity over a concentration range of 10µg/ml to 250µg/ml with r²=0.999 and thus this represents the method is efficient to provide good detector response. The lower limit of detection and quantification was achieved by carrying out the studies like LOD and LOQ and the results were found to be 10µg/ml and 5µg/ml respectively.

Keywords: Method validation, reverse phase-HPLC, itraconazole ointment, limit of detection, limit of quantification. forced degradation.

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Rilpivirine and Cabotegravir in dosage form. Chromatogram was run through AgilentC18 150 x 4.6mm, 5.0mm.¹ Mobile phase containing Buffer 0.1% Ammonium Acetate: Acetonitrile taken in the ratio 55:45v/v was pumped through the column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. The optimized wavelength selected was 260 nm. The retention time of Rilpivirine and Cabotegravir was found to be 2.238 min and 2.953 min. %RSD of the Rilpivirine and Cabotegravir was found to be 0.5 and 0.5 respectively. %Recovery was obtained as 99.85% and 99.84% for Rilpivirine and Cabotegravir respectively. LOD and LOQ values obtained from regression equations of Rilpivirine and Cabotegravir were 0.11, 0.3,2, and 0.02, 0.06 respectively.² The regression equation of Rilpivirine is y = 17712x + 2324.3 and y = 17293x + 1410.5 of Cabotegravir Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.  

Keywords: Rilpivirine, Cabotegravir, RP-HPLC, Validation.

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Bempedoic acid and Ezetimibe in bulk and tablet dosage form.⁽¹⁾ Chromatogram was run through Kromosil C18 150 x 4.6 mm, 3.0m. Mobile phase containing 0.01N Kh2Po4 Buffer: Methanol taken in the ratio 70:30 was pumped through the column at a flow rate of 0.9ml/min. The buffer used in this method was 0.01N Kh2Po4 buffer. Temperature was maintained at 30°C. The optimized wavelength selected was 260.0 nm. The retention time of Bempedoic acid and Ezetimibe was found to be 2.780min and 2.123min. %RSD of the Bempedoic acid and Ezetimibe were found to be 0.6 and 1.3 respectively. % Recovery was obtained as 99.87% and 100.12% for Bempedoic acid and Ezetimibe respectively. LOQ, and LOD values obtained from regression equations of Bempedoic acid and Ezetimibe were 0.10, 0.35, and 0.01, 0.03 respectively. The regression equation of Bempedoic acid is y = 28262x + 4418.6, and y = 28796x + 190.13 of Ezetimibe. Retention times were decreased and that run time was decreased, so the method developed was simple and economical and can be adopted in regular Quality control tests in Industries.       

Keywords: Bempedoic acid, Ezetimibe, RP-HPLC

ABSTRACT

The aqueous extract of unripe fruit of Baccuarea courtallensis were assessed for its anti-oxidant potential. The aqueous extract was subjected to in-vitro anti-oxidant screening by reduction of ferric ions. Ascorbic acid was used as standard. The study reveals that the aqueous extract of the unripe fruit has potent anti-oxidant activity. The activity exhibited by the fruit extract was comparable with the reference standard used in the evaluation. The anti-oxidant activity was found to be concentration dependent and may be attributed to the presence of flavonoid content in the fruits.

Keywords: Aqueous extract, Baccaurea courtallensis, ferric ions, anti-oxidant screening