Development and Validation of RP-HPLC Method for Simultaneous Estimation of Dapagliflozin and Telmisartan in Synthetic Mixture

Abstract

The current’s work objective is to propose and validate straight-forward and robust RP-HPLC method for concurrent determination of Dapagliflozin (DAP) and Telmisartan (TEL) in blend.  A 150 × 4.6 mm, 5 µm Nucleosil ODS C18 Column was used for the separation, which was kept at 35 °C. Methanol and buffer (25:75% v/v) were used as the eluent, flowing at a rate of 1.0 mL/min with a detection wavelength of 224 nm. The injection volume was 40 µL. In compliance with ICH criteria, the analytical approach was successfully validated (ICH Q2 R1). Retention time for DAP and TEL were 4.78 and 7.77 min individually. DAP and TEL showed linear response from 5-15 µg/mL and TEL from 40 -120 µg/mL with correlation coefficient (r) as 0.9989 and 0.9988 individually. The outcomes of accuracy and precision were found within the acceptance range. Limit of Detection (LOD) is 1.33 and 10.87 µg/mL & Limit of Quantitation (LOQ) is 4.05 and 32.94 µg/mL for DAP and TEL, individually. The current approach was found precise, accurate, robust and could be beneficially utilized for the concurrent analysis of DAP and TEL in dosage form.