Method development and validation for the simultaneous estimation of sitagliptin and metformin in tablet dosage form by RP-HPLC

Abstract

A RP-HPLC method was developed and validated for the simultaneous estimation of Metformin Hydrochloride (MET) and
Sitagliptin (STG) in pure and pharmaceutical dosage form. Chromatography was carried on Phenomex (kromosil-250 mm ×
4.6 mm, 5 μm) column with mobile phase comprising of phosphate buffer and acetonitrile in the ratio 75:25 v/v. The flow
rate was adjusted to 1.0 ml/min with UV detection at260 nm. The retention times of MET and STG were found to be 1.43
min, 2.3 min respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, limit of
detection (LOD), limit of quantification (LOQ) were determined according to the ICH-Q2B guidelines. The detector response
was linear in the range of 25-250 μg/ml, 2.5-25 μg/ml for MET, STG respectively. The proposed RP-HPLC method is
sensitive, precise and accurate so it was successfully applied for the reliable quantification of drugs in the commercial dosage
form.