DEVELOPMENT AND VALIDATED UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF FIMASARTAN IN PURE AND PHARMACEUTICAL DOSAGE FORMS

Pharmaceutical analysis

A simple, precise, accurate, cost effective stability indicating UV- spectrophotometric method has been developed for the estimation of Fimasartan in bulk and tablet dosage form. Fimasartan shows highest λmax at 261 nm. Beer's law (linearity response) was found over a concentration range of 10-50 μg /mL with good correlation coefficient (r2 = 0.999). The detection limit (DL) & quantitation limit (QL) were found to be 0.002 mcg/mL and 0.001 mcg/mL respectively. The results of the Fimasartan recovery analysis were found to be 96.80±0.001 to 98.28±0.002. Percentage assay of Fimasartan tablets (Fimanta) got more than 99.96 %. The proposed spectrophotometric method was validated as per the ICH Q1A (R2) guidelines. While estimating the Fimasartan in tablet formulation, there was no interference of additives & excipients. Hence this method can be safely being employed for the routine quality control analysis of Fimasartan in bulk and tablet dosage form.

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