Abstract

STABILITY- INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF OXAPROZIN

Atul Nagar*, Santosh Prajapati and Dr. Purnima D. Hamrapurkar

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Abstract

A simple, sensitive, precise, and validated RP-HPLC method has been developed for the analysis of Oxaprozin API and for its stabilityindicating assay. The solvent system and wavelength were optimized in order to maximize the sensitivity of the proposed method; Oxaprozin shows the maximum absorbance at 220 nm by using a PDA detector. A Waters HPLC system, with Hemochrom C18 column 150 mm X4.6mm column is employed for the analysis using Acetonitrile and 0.1% Formic acid in the ratio of 60:40 respectively as mobile phase. The method was validated for accuracy, precision, linearity, specificity, stressed studies, robustness, etc. Linearity was observed in the concentration range of 1-5% and gave a mean correlation coefficient of 0.999. The developed RP-HPLC method was found to be accurate, precise, and stability indicating, and has application in API pharmaceutical manufacturing.

Keywords: Oxaprozin, RP-HPLC, Development, Validation, Forced degradation.