A Review on Development and Validation of Analytical Methods for Simultaneous Estimation of Dapagliflozin, Linagliptin and Metformin in Pharmaceutical Dosage Form

A chronic metabolic disease called diabetes mellitus is typified by high blood glucose levels brought on by deficiencies in either insulin action or production, or both. It is still one of the most common and difficult worldwide health problems, and in order to obtain the best glycemic control, combination medication is frequently needed. Dapagliflozin (an SGLT2 inhibitor), linagliptin (a DPP-4 inhibitor), and metformin (a biguanide) are three pharmacological alternatives that have drawn a lot of attention because of their complimentary mechanisms of action and better patient outcomes when taken in combination therapy. Numerous analytical techniques for estimating these medications separately in pharmaceutical dosage forms and bulk have been reported. Additionally, many studies have utilized techniques like high-performance liquid chromatography (HPLC), UV-visible spectrophotometry, and high performance thin-layer chromatography (HPTLC) to describe validated methods for their binary combinations, such as dapagliflozin with metformin, linagliptin with metformin, and dapagliflozin with linagliptin. Nevertheless, a thorough examination of the literature shows that no analytical technique has been created or approved as of yet for the simultaneous measurement of metformin, linagliptin, and dapagliflozin in a single formulation. The published analytical techniques for both individual and binary mixes of these antidiabetic drugs are critically compiled and assessed in this study. The article also emphasizes the need and potential for creating a new, trustworthy, and strong analytical technique for their simultaneous measurement. Regular quality control, the development of fixed-dose combination (FDC) products, and regulatory compliance would all greatly benefit from such a technique. Future studies aimed at creating and validating a single analytical technique for this promising triple-drug combination in the management of type 2 diabetes mellitus will be built upon the results of this review.