The development of accurate and reliable analytical methods is essential for the quantitative estimation of pharmaceutical compounds in combined dosage forms. Linagliptin, Dapagliflozin, and Metformin Hydrochloride are widely used antidiabetic agents belonging to different pharmacological classes—DPP-4 inhibitor, SGLT2 inhibitor, and biguanide, respectively. Their combination therapy offers synergistic control over blood glucose levels in patients with type 2 diabetes mellitus. This review provides a comprehensive overview of various UV-spectrophotometric and reversed-phase high-performance liquid chromatographic (RP-HPLC) methods developed and validated for the simultaneous determination of these three drugs in bulk and tablet dosage forms. Emphasis is placed on method development parameters such as selection of detection wavelength, mobile phase composition, stationary phase, flow rate, retention time, linearity range, and validation as per ICH guidelines. The comparative assessment highlights that RP-HPLC methods demonstrate superior sensitivity, selectivity, and precision compared to UV methods, although UV-spectrophotometry remains advantageous for routine, cost-effective analysis in resource-limited laboratories. The review concludes that optimized RP-HPLC methods are more suitable for the simultaneous estimation of Linagliptin, Dapagliflozin, and Metformin Hydrochloride in fixed-dose formulations for routine quality control applications.
Dr. Dhara Vashi2 Vasava Simran Maheshbhai*1 (Sat,) studied this question.