Department of Pharmaceutical Chemistry and Analysis, CMR College of Pharmacy, Kandlakoya, Medchal-Malkajgiri-501401, Telangana, India
The two main treatments for type 2 diabetes mellitus are sitagliptin and metformin, which are frequently taken together to provide the best possible glycemic control. The objective of this review is to critically assess analytical and bioanalytical methods for measuring metformin and sitagliptin, either separately or together, in biological matrices and pharmaceutical formulations between 2005 and 2025. Titrimetric analysis, spectrophotometry, chromatography (high-performance and ultra-performance liquid chromatography), electroanalytical methods, capillary electrophoresis, and chemometric approaches are among the techniques evaluated. While spectrophotometry delivers routine analysis at a reasonable cost, chromatography offers excellent sensitivity and resilience, making it perfect for complicated matrices. Chemometric techniques improve data interpretation, whereas capillary electrophoresis and electroanalytical techniques guarantee accuracy for particular applications. Each method's validation metrics, including specificity, accuracy, and reproducibility, were examined. Applications include therapeutic monitoring, pharmacokinetic research, and quality control. High equipment expenditures for sophisticated methods and matrix interference in biological samples are among the drawbacks. Method procedures are made clearer by schematic workflows, which also help choose techniques according to matrix complexity, cost, and sensitivity. According to this review, the choice of method is contingent upon the analytical requirements; chromatography is a diverse but resource-intensive technique, while spectrophotometry and other simpler methods are better suited for everyday work. These observations help researchers optimize metformin and sitagliptin measurement techniques, promoting improvements in diabetes care.
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by persistent hyperglycemia resulting from a combination of insulin resistance and impaired insulin secretion. With the global prevalence of T2DM rising at an alarming rate, it has become a major health concern contributing significantly to morbidity, mortality, and healthcare costs worldwide. The World Health Organization (WHO) has identified diabetes as one of the most critical non-communicable diseases of the 21st century, necessitating effective therapeutic interventions to prevent its associated complications, including nephropathy, neuropathy, retinopathy, and cardiovascular diseases. Sitagliptin and Metformin combination therapy has become a mainstay in the treatment of type 2 diabetes among the several pharmacotherapeutic strategies that are available. By improving the incretin system and selectively inhibiting Dipeptidyl Peptidase-4 (DPP-4), sitagliptin promotes glucose-dependent insulin secretion while blocking glucagon release. Inhibiting hepatic gluconeogenesis and enhancing peripheral insulin sensitivity are the main ways that the biguanide drug metformin reduces blood sugar. These two medications work in concert to improve glycemic control while reducing the risk of weight gain and hypoglycemia. This results in a good safety and effectiveness profile for long-term treatment. According to its chemical designation, sitagliptin is (R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro [1, 2, 4]. triazolo [4,3-a] [pyrazin-7(8H)-yl] The chemical formula for -1-(2,4,5-trifluorophenyl) butan-2-amine is C16H15F6N5O, and its molecular weight is 407.31 g/mol. It is a crystalline powder that ranges from white to off-white and dissolves somewhat in water and somewhat in phosphate buffer. 1,1-dimethylbiguanide hydrochloride, the chemical name for metformin, is a white, crystalline substance with a molecular weight of 165.63 g/mol, a molecular formula of C4H11N5•HCl, and a high-water solubility. Both medications are recognized by several pharmacopoeias, including as the IP, BP, and USP. Numerous analytical techniques have been developed to precisely quantify sitagliptin and metformin in bulk materials, pharmaceutical formulations, and biological matrices due to their growing use as monotherapy and in fixed-dose combos. UV-visible spectrophotometry, capillary electrophoresis, high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), electroanalytical techniques, and hyphenated techniques like LC-MS/MS are among the methods used for their analysis. The goal of this review is to present a thorough and critical analysis of the analytical methods used for sitagliptin and metformin estimates in the literature from 2006 to 2024. These techniques fall into the following analytical domains: (1) spectrophotometric techniques, (2) chromatographic techniques, (3) electroanalytical approaches, (4) capillary electrophoretic techniques, and (5) hyphenated and chemometric-assisted strategies. It covers the development, benefits, drawbacks, and applicability of these techniques. This article intends to assist researchers, pharmaceutical analysts, and regulatory professionals in choosing suitable techniques for the qualitative and quantitative evaluation of sitagliptin and metformin in various matrices by providing a thorough and structured overview of the current analytical landscape.
Fig. 2. Metformin
Manda Sreekanth*, Konda Sri Vaishnavi, Padugula Sowmya, Nenavath Kanakaraju, Tadikonda Rama Rao, Validated Analytical Approaches for Sitagliptin Monohydrate and Metformin: A Critical Review, Int. J. Sci. R. Tech., 2025, 2 (6), 472-482. https://doi.org/10.5281/zenodo.15675876
10.5281/zenodo.15675876
