Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF REMOGLIFLOZIN ETABONATE BY UV-VISIBLE SPECTROSCOPY

Dillan Kumar*, Sreenivas Rao T., Chandanam Sreedhar, Kumari Khushboo and Harsha K. Tripathy

ABSTRACT

Remogliflozin Etabonate is primarily used in cases of non-alcoholic steatohepatitis and type-2 diabetes and recently developed insulin-independent oral hypoglycemic agent. The aim was to develop a new analytical UV-Visible Spectroscopy method, sensitive, rapid, accurate, and precise approach for Remogliflozin Etabonate which was validating as per ICH guidelines. PC-based double beam spectrophotometer 1700 was used to do UV Visible Spectrophotometric measurement. Using methanol as a medium, run in the range of 200-400 nm with fast mode to determine Maxima that was obtained at 227nm. Concentration range of 10-60 μg/ml gives correlation coefficient of 0.9999. The limits of detection (LOD) and limit of quantitation (LOQ) were found to be 0.47 and 1.42, respectively. The precision, Accuracy were expressed as relative standard deviation(%RSD) that was less than 2. The proposed UVvisible spectroscopy method and its validation according to the ICH guidelines shows that develop method is sensitive, precise, accurate and simple for the determination of Remogliflozin Etabonate in bulk and pharmaceutical Dosage forms.

Keywords: Remogliflozin Etabonate, Analytical Method Validation, UV.