• A Sree Geetha
• B.Hema Kiranmayi
• K.Sai Priyanka
• Dr.J.Anu Pravallika

The present study focuses on the development and validation of a robust, cost effective UV spectrophotometric method for the estimation of empagliflozin, an SGLT2 inhibitor widely used in the management of type 2 diabetes. This method adheres to ICH guidelines and incorporates forced degradation studies to assess the stability of Empagliflozin under various stress conditions. Standard and sample solutions are prepared using methanol and water in the ratio of 70:30.The absorption maxima λmax was obtained at 223nm.Thecalibration curve was linear in the range of 2-10µg/ml. The %RSD for both intra and inter day precision was found to be 0.92 and 1.2 respectively. Percentage recovery of empagliflozin was found to be within 97-102% and the assay of the formulation was 101.2%. LOD and LOQ value of the standard drug was found to 0.44 and 1.34. The % RSD for robustness and ruggedness was found to be less than 2% . Forced degradation studies including exposure to acidic, basic, oxidative, thermal, and photolytic conditions, revealed critical insights into the degradation pathways of the drug, supporting its stability profile. This approach demonstrates the efficacy of UV- method in routine pharmaceutical analysis providing a comprehensive understanding of the drug’s stability paving way for enhanced quality control and regulatory compliance.

Emplagliflozin, UV spectroscopy, absorption maxima, RSD, Forced degradation, regulatory compliance.

"DEVELOPMENT VALIDATION AND FORCED DEGRADATION STUDIES OF EMPAGLIFLOZIN USING UV-SPECTROSCOPY IN A COMPREHENSIVE APPROACH", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 5, page no.d928-d935, May-2025, Available :http://www.jetir.org/papers/JETIR2505455.pdf

"DEVELOPMENT VALIDATION AND FORCED DEGRADATION STUDIES OF EMPAGLIFLOZIN USING UV-SPECTROSCOPY IN A COMPREHENSIVE APPROACH", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 5, page no. ppd928-d935, May-2025, Available at : http://www.jetir.org/papers/JETIR2505455.pdf