Development and Validation RP-HPLC Method for Simultaneous Estimation of Dapagliflozin and Saxagliptin in Bulk and Pharmaceutical Dosage Form

Abstract

A simple, precise, sensitive, and rapid reverse phase high performance liquid chromatographic method was developed and validated for simultaneous estimation of Dapagliflozin (DAPA) and Saxagliptin (SAXA) in bulk as well as in tablet formulation according to the ICH guidelines. The chromatographic phase consisted by phosphate buffer: Acetonitrile, pH 4.0 adjusted by glacial acetic acid. The flow rate was adjusted to 0.8 ml/min and UV detection was carried out at 220 nm. Retention time was found to be 2.144 and 3.156 min; respectively. The detector was showed that linear responses over the concentration range 10–24 μg/ml for SAXA and 12–40 μg/ml for DAPA a good correlation coefficient of 0.999. This proposed method is highly sensitive, precise, and accurate which reduces cost of analysis; hence, recommended for routine quality analysis in laboratories.