Validation for Simultaneous Estimation of Sitagliptin and Simvastatin by RP-HPLC

Abstract

Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. The linearity was observed in the range of 60-140 and 24-56 µg/ml with a Correlation Coefficient of 0.998 and 0.994 respectively. The %RSD of Sitagliptin and Simvastatin for precision was found to be 0.39 and 0.98 respectively. The recovery of Sitagliptin and Simvastatin was found to be 99.4-100.34% and 101.27-101.69% respectively which shows the accuracy of proposed method. The proposed method was validated for its linearity, accuracy, precision and robustness. This method can be employed for routine quality control analysis of Sitagliptin and Simvastatin tablet dosage form.