METHOD DEVELOPMENT AND VALIDATION OF SITAGLIPTIN AND SIMVASTATINE IN TABLET DOSAGE FORM BY RP-HPLC

A simple and selective LC method is described for the determination of Sitagliptin and Simvastatin in tablet dosage forms. Chromatographic separation was achieved on a c₁₈ column using mobile phase consisting of a mixture of 80 volumes of methanol and 20 volumes of water with detection of 241 nm. Linearity was observed in the range 60-140µg /ml for Sitagliptin (r² =0.997) and 61-155µg /ml for Simvastatin (r² =0.997) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. From the above experimental results and parameters, it was concluded that, this newly developed method for the simultaneous estimation Sitagliptin and Simvastatin was found to be simple, precise, accurate and high resolution and shorter retention time makes this method more acceptable and cost effective and it can be effectively applied for routine analysis in research institutions, quality control department in meant in industries, approved testing laboratories studies in near future.

Keywords: Sitagliptin, Simvastatin, RP‐HPLC, Simultaneous estimation.