DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN BULK AND PHARMACEUTICAL DOSAGE FORMS

摘要

An analytical method consists of a detailed, stepwise list of instructions to be followed in the qualitative, quantitative, or structural analysis of a sample for one or more analytes and using a specified technique. A novel, simple, precise, sensitive, and reproducible RP-HPLC method for the simultaneous estimation of Dapagliflozin and Saxagliptin in bulk and pharmaceutical formulation was developed and validated. The separation was carried out on Symmetry C 8 (4.6 × 150 mm, 3.5 μm, Make: XTerra) column with buffer: acetonitrile in the ratio of 70:30 %v/v (pH 3) as the mobile phase at the flow rate of 1 ml/min. The eluent detection was carried out using a UV-Visible detector at 221 nm. The retention time of Dapagliflozin and Saxagliptin was 2.83 min and 4.35 min, respectively. Linearity was observed Dapagliflozin and Saxagliptin in the concentration range of 25-125 μg/ml and 12.5-62.5 μg/ml, respectively. The % mean recovery of Dapagliflozin and Saxagliptin was found to be 99.90 and 99.99, respectively. The present study demonstrates the applicability of chromatographic method to develop a new, sensitive, single RP-HPLC method for the simultaneous quantitative determination of Dapagliflozin and Saxagliptin in a fixed pharmaceutical dosage form. Hence, this method can be conveniently adopted for routine analysis in quality control laboratories.