Analytical Methodologies for Linagliptin, Dapagliflozin Propanediol Monohydrate and Metformin Hydrochloride: A Comprehensive Review of Rp-HPLC and HPTLC Techniques

ABSTRACT:Types 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulinresistance, pancreatic -cell dysfunction, and persistent hyperglycaemia. Combinationtherapy using drugs with complementary mechanisms has become an effective strategy forimproved glycaemic control. Metformin hydrochloride, Dapagliflozin propanediolmonohydrate, and Linagliptin are widely used antidiabetic agents. Metformin reduces hepaticglucose production and improves insulin sensitivity, Dapagliflozin promotes renal glucoseexcretion by inhibiting sodium-glucose co-transporter-2(SGLT-2), and Linagliptin inhibitsdipeptidyl peptidase-4(DPP-4). Accurate and validated analytical methods are required fortheir simultaneous determination in pharmaceutical formulations. The great sensitivity,selectivity, and precision of (RP-HPLC) make it a popular technique. In addition todiscussing important chromatographic parameters such mobile phase composition, stationaryphase, detection wavelength, flow rate, and retention time, this study summarizes RP-HPLCtechniques described for the simultaneous identification of these medicines. The internationalcouncil for harmonization (ICH) guidelines are followed when discussing validationcharacteristic like as accuracy, precision, linearity, specificity, LOD, LOQ, and robustness.The development of a dependable RP-HPLC technology for routine pharmaceutical analysisand quality control of various antidiabetic medications in combination dosage forms ishighlighted throughout the review.