An Overview on Analytical Method Development and Validation for Ertugliflozin in Bulk and Pharmaceutical Dosage form

• Published in: Asian Journal of Pharmaceutical Analysis Vol. 13; no. 3; pp. 222 - 228
• Main Authors: M. Sagar, Priyanka, Mankar, S.D., Dighe, S. B.
• Format: Journal Article
• Language: English
• Published: Raipur Athena Information Solutions Pvt. Ltd 07.09.2023
• Subjects: Antidiabetics; Bioavailability; Diabetes; Drug dosages; FDA approval; Glucose; Insulin; Metabolism; Oral administration; Particle size; Pharmaceutical industry; Pharmaceuticals; Potassium; Proteins; Retention; Sodium; Urine
• ISSN: 2231-5667; 2231-5675
• DOI: 10.52711/2231-5675.2023.00036

Diabetes mellitus (DM) is a metabolic condition characterized by hyperglycemia, glycosuria, hyperglycemia, a negative nitrogen balance, and occasionally ketonemia. The type 2 sodium-dependent glucose co-transporters (SGLT), which are in charge of roughly 90% of the reabsorption of glucose from the glomerulus, are subject to strong and selective inhibition by ertugliflozin. This review's primary objective is to highlight the development and validation of analytical methods employing chromatographic and spectrophotometric techniques for ertugliflozin and combination products in bulk and pharmaceutical dose forms. RP-HPLC, UV, UPLC, and LC-MS techniques are used to determine the dosage of ertugliflozin when it is combined with metformin and sitagliptin. Spectrometric techniques for ertugliflozin in combination with metformin or sitagliptin contain parameters like solvent, wavelength, linearity, LOD, LOQ, etc., and HPLC methods for ertugliflozin in combination with metformin or sitagliptin include parameters like stationary phase, mobile phase, RT, detection wavelength, LOD, LOQ, etc. Discussions on the separation requirements for ertugliflozin in combination with metformin or sitagliptin are also addressed throughout this review.