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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