Method Development and Validation of Sitagliptin and Simavastatin in Tablet Dosage Form by Rp-HPLC

Abstract

A simple, sensitive, and precise RP-HPLC method for the simultaneous estimation of Sitagliptin (SIT) and Simvastatin (SIM) combined dosage form has been developed and validated. The components were well separated using Agilent C8 (4.6 x 150mm, 3.5µm) column using phosphate buffer (ph-6.26): Acetonitrile in the ratio 25:75 as mobile phase at a flow rate of 0.8 mL/min. The eluents were detected at 254 nm using UV detector. The retention times of SIT and SIM were found to be 2.475min and 6.528min for Simvastatin and Sitagliptin respectively. The linearity was observed in the range of 80-120 µg/mL for SIT and 16-24µg/mL for SIM. The marketed dosage form was analyzed by using the developed method and the percent content of SIT and SIM were found to be 99.67 – 100.27 %  and 99.42 – 100.54%. The developed method was validated for parameters like system suitability, specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines and the results were found to be within the limits. The validated method was used for the stability studies (short, long and auto sampler) and forced degradation studies (acidic, alkaline, oxidative and photolytic). Both SIT and SIM were found to be stable in all conditions. This validated method can be used for the routine quality control testing of SIT and SIM combined dosage form.