“a Review on Analytical Method Development and Validation of Dapagliflozin: a Comprehensive Review”
Year: 2025
Type: article
Abstract: Dapagliflozin, a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, is widely prescribed for the management of type 2 diabetes mellitus due to its novel mechanism of promoting renal glucose excretion and improving glycemic control. With its growing clinical use and the availability of multiple fixed-dose combinations, the need for reliable, validated analytical methods to support drug development, formulation, quality control, and regulatory compliance has increased significantly. This comprehensive review summarizes the various analytical techniques reported for dapagliflozin, including UV-spectrophotometry, RP-HPLC, UPLC, LC-MS/MS, and stability-indicating assays. The article discusses the application of these methods in bulk drug and dosage form assay, simultaneous estimation in combination formulations, forced-degradation and stability studies, impurity profiling, bioanalytical quantification in plasma for pharmacokinetic studies, and dissolution testing. Validation parameters such as linearity, precision, accuracy, sensitivity (LOD/LOQ), robustness, and specificity, as outlined by ICH guidelines, are highlighted across reported methods. Special emphasis is given to stability-indicating methods that separate dapagliflozin from its degradants under acid, base, oxidative, photolytic, and thermal conditions. Despite the effectiveness of conventional methods, challenges such as the use of phosphate buffers and large volumes of toxic organic solvents raise concerns about instrument damage, operator safety, cost, and environmental sustainability. To overcome these limitations, emerging trends focus on developing greener, eco-friendly, and high-throughput analytical approaches. In conclusion, the review provides an updated and detailed insight into existing analytical strategies for dapagliflozin, while also emphasizing the future need for simple, robust, cost-effective, and environmentally sustainable methods. These advancements will play a crucial role in ensuring the safe and efficient use of dapagliflozin in pharmaceutical development, routine quality control, and clinical research.
DOI: 10.53555/rrykrb89
Author: Dhruvi V Patel
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
OpenAlex ID: W7084087159
FWCI:
Cites:
Cited by:
Related to: