A Current Review on Analytical Tools for Determination of New Oral Antidiabetic Drugs, Empagliflozin, Linagliptin and Biguanides in Bulk Materials, Pharmaceuticals & Biological Samples

Abstract

Worldwide the R & D divisions of Pharma industry are actively involved in the development of new therapeutic agents. These agents may be either new entities or partial structural modification of the existing one. The recent FDA statistics represent that the average number of drug filings are increasing every year in the thrust areas like anti-cancer agents, anti-diabetic, antibiotics, cardio-vascular drugs, respiratory drugs etc. Sodium glucose co-transporter-2(SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors and biguanides are effective oral anti-diabetic agents used in treatment of type 2 Diabetes Mellitus. Therefore, the necessity to explore and compare the existing analytical and bioanalytical assays used for determination of such drugs either single or in combination is crucial. Many methods were reported in the literature for the bio-analysis and analysis of four novel gliptins combinations, empagliflozin-linagliptin, empagliflozin-metformin HCl, linagliptin-metformin HCl, empagliflozin-linagliptin-metformin HCl combination with application on Glyxambi®, Synjardy®, Jentadueto®, Trijardy® XR tablets respectively. Furthermore, this review offered an overview of different methods used for determination of every drug alone as empagliflozin from SGLT-2 inhibitors, linagliptin from DPP-4 inhibitors and metformin from biguanides in a tabulated comparative way. Moreover, the current review emphasizes the most common stability indicating assays to be of interest to the analysts in the area of drug control. This review helps in understanding the further need for the development of analytical methods for the estimation of such drugs.