Harshal S. Pawar1*, Madhuri A. Bhole1, Swapnil R. Patil2, Kalpesh V. Sonar1
1.Department of Pharmaceutical Chemistry, Arunamai college of Pharmacy, North Maharashtra University, Mamurabad, Jalgaon (MH), INDIA 425001.
2.Department of Pharmaceutics, Vidya Bharati College Of Pharmacy, Amravati University, Amravati (MH), INDIA 444602.
To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Lansoprazole in Capsule dosage form. The drug is soluble in analytical grade Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade Methanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Lansoprazole in Capsule dosage form and also validated as per ICH guidelines. The drug is freely soluble in Dimethylformamide, soluble in analytical grade Methanol, sparingly soluble in Ethanol, slightly soluble in Ethyl Acetate, Dichloromethane and Acetonitrile. So, the analytical grade Methanol is used as a diluent in method. The melting point of Lansoprazole was found to be 179-180ËšC (uncorrected). It showed absorption maxima 285 nm in analytical grade Methanol. On the basis of absorption spectrum the working concentration was set on 10µg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 99.00 and 100.80 % for three levels respectively. The % RSD for precision was found to be 0.9039 %.A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Lansoprazole in Capsule dosage form. The method could be considered for the determination of Lansoprazole in quality control laboratories.
Keywords: Lansoprazole, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.