Abstract
In this study, a simple and efficient HPLC analytical method has been proposed and validated for the simultaneous detection and quantification of metformin hydrochloride and empagliflozin in bulk pharmaceutical products. The composition of ammonium dihydrogen phosphate buffer (pH 3.0) with methanol in the ratio of 45:55 v/v was used as mobile phase for chromatographic runs. The separation of both analytes was performed on a mu Bondapack (R) C18 column (250 x 4.6 mm x 2.6 mu m) using isocratic mode. The sharp peaks of both drugs were obtained at 224 nm using UV detector. The proposed method was linear at the concentration range of 5-150 mu g/mL for metformin and 2.5-150 mu g/mL for empagliflozin. The developed method was also validated using guidelines of International Conference of Harmonisation (ICH), in term of system suitability, accuracy, recovery, specificity, linearity, precision, robustness, limit of detection (LOD) and limit of quantitation (LOQ). The values of LOD and LOQ of developed analytical method were 0.86 mg/mL and 2.42 mg/mL for metformin, and 0.89 mg/mL and 2.53 mg/mL for empagliflozin, respectively.