METHOD DEVELOPMENT AND VALIDATION OF OLMESARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE IN COMBINED TABLET DOSAGE FORM
Journal Title: Int J of Pharm Res & Analy - Year 2011, Vol 1, Issue 1
Abstract
A simple, accurate, precise, economical and reproducible method was developed for simultaneous estimation of olmesartan, amlodipine and hydrochlorothiazide in bulk and its dosage form. The excipients in the commercial tablet preparation did not interfere with the assay. Here we have developed a validated simultaneous estimation of olmesartan, amlodipine and hydrochlorothiazide in bulk and its tablet formulation. The stock solutions were prepared in methanol followed by the further required dilutions with Double distilled water. The λmax for olmesartan, amlodipine and hydrochlorothiazide were 256.5 nm, 239 nm and 271.5nm respectively. Linearity in concentration range of 4-24 µg/ mL, 1-10 µg/ mL and 2-20 µg/mL was shown respectively by the three drugs. The proposed method has estimated olmesartan 99.45±0.94%, amlodipine 98.95±0.32% and hydrochlorothiazide 100.46±0.68% in marketed tablets. The results of analysis have been validated statistically and also by recovery studies. Validation of the proposed methods was carried out for its accuracy, precision, and ruggedness according to ICH guidelines. Thus the present study gives an excellent method for the determination of all the three drugs in combined dosage formulation without their prior separation.
Authors and Affiliations
J. Saminathan , T. Vetrichelvan
Keywords
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