DEVELOPMENT AND VALIDATION OF RP-HPLC ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF PHENTERMINE AND TOPIRAMATE IN PURE AND ITS PHARMACEUTICAL DOSAGE FORMS
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2014, Vol 5, Issue 7
Abstract
Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A simple, rapid, precise, and reliable simultaneous stability indicating RP - HPLC method was developed for the separation and estimation of two drugs phentermine and topiramate in bulk drug mix and pharmaceutical dosage forms. An isocratic separation was achieved using a phenyl column with a flow rate of 1 mL/min using UV detection at 263 nm. Phentermine dose not has and topiramate has low UV absorbtivity and was subjected to derivatization with 9-fluorenylmethylchloroformate (FMOC-Cl). The mobile phase for the separationconsisted of acetonitrile: 50 mM sodium dihydrogen phosphate (NaH2PO4) containing 3 % v/v triethylamine (pH 2.8) in a 55:45 v/vratio at a flow rate of 1.0mL min using phenyl column. and UV detectionwas performed at 263 nm. Total run time was 10 min; Phentermine and topiramate were eluted with retention times of 2.72 min and 6.13 min, respectively. The method was validatedfor accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines.Validation revealed that the method is specific, rapid, accurate, precise, reliable, and reproducible.The high recovery and low coefficients of variation confirmed the suitability of the method forsimultaneous analysis of the two drugs in tablet dosage form.
Authors and Affiliations
Kavitha K. Y, Geetha G, Hariprasad R, Venkatnarayana R, Subramanian G
Keywords
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- EP ID EP126798
- DOI 10.7897/2230-8407.0507125
- Views 127
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