Affiliation:
1. Department of Pharmaceutical Chemistry, P. R. Pote Patil College of Pharmacy, Amravati – 444602.
Abstract
Remoglifozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor, which is to be administered as remoglifozinetabonate (Remo™, Remozen™), the prodrug for remoglifozin, recently received its first approval as a treatment for type 2 diabetes mellitus (T2DM) in India. A sensitive, precise and stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed for analysis of Remogliflozin Etabonate in tablet formation. Type and diabetes mellitus (T&PM) is an emerging epidemic in Asian countries, especially in India. Remogliflozin Etabonate is the latest addition to the SGTL2 inhibitor class of drug that have been recently appeared in India for management of T2DM. Remogliflozin Etabonate is a potent an selective inhibitor of SGLT2 with the unique distinction of being administered as a prodrug exitstence of active metabolities and short half-live necesstating twice daily dosing. The phase III study of Remogliflozin Etabonate demostrated it to be an efficacious and safe agent and remogliplgin a selective O-linked glycocide inhibitor of SGLT2, Remogliflozin Etabonate increase urine glucose excration and reduces plasma glucose concentration and decreased body weight. Remogliflozinetabonate shows Maximum Absorbance at 229nm. Beer’s law was obeyed in range of 2-10µg/ml. The correlation coefficient was found to be 0.9990. The result of interday and intraday precision shows standard deviation ranging from 0.050% - 0.254% and 0.058% - 0.258% for three concentration and three replicates. The Percentage recovery was found to be in the range of 98.94% - 99.86%. The LOD and LOQ were found to be 0.037µg/ml and 0.113µg/ml respectively. The purposed method was novel and successfully applied for the determination of Remogliflozin Etabonate in Tablet Dosage Form.
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