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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR RIMONABANT AND ITS IMPURITIES IN ACTIVE PHARMACEUTICAL INGREDIENT

Kandimalla Srinivasarao and K. Vasantha Kumar Pai*

ABSTRACT

The simple isocratic RP-LC method developed for the quantitative determination of Rimonabant assay, related compounds and its possible degradation products is precise, accurate and specific to analyze Rimonabant in bulk active substance. The method was fully validated showing satisfactory data for all the method validation parameters tested. The developed method is stability indicating and can be used for the routine analysis of production samples and also to check the stability of bulk samples to establish the retest period for Rimonabant.

Keywords: Imonabant, SOC12/Toluene, piperidin-1-amine/TEA/DCM.


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