Development and Validation of Analytical Methods for Simultaneous Estimation of Voglibose, Sitagliptin and Metformin Hydrochloride in Bulk and Tablet Dosage Form by Rp-Hplc.

Abstract

The RP-HPLC method was developed to determine the levels of metformin HCl (MET), sitagliptin (SIT), and voglibose (VGB) in an inexpensive, accurate, precise, and repeatable manner. With a fine ODS C18 column (250mm) and a mobile phase mixture including a mixed acetonitrile: phosphate buffer ratio of 85:15 (PH 4), the RP–HPLC method was developed on LC2030C plus HPLC equipment. The effluent was measured at 242 nm, and the flow rate was 1 ml/min. Voglibose, Sitagliptin, and Metformin HCL had respective retention times of 4.9, 3.7, and 3.0 minutes. Linearity, precision, accuracy, specificity, and system appropriateness characteristics were used to validate the approach. For MET, VOG, and SIT, the calibration curves were linear with regression coefficients of 1, 0.9999, and 0.9998, respectively, at concentration ranges of 10–50 μg/ml, 1–5 μg/ml, and 10–50 μg/ml. The results of the suggested approach were deemed satisfactory and appropriate for the simultaneous determination of voglibose, sitagliptin, and metformin HCl for routine quality control of medicines in bulk and formulation. The results were exact with (%) relative standard deviation.