Bioequivalence Study and Bioanalytical Method Development of Remogliflozin etabonate tablets in wistar rat plasma using RP-HPLC Method

Abstract

A new RP-HPLC method for the bioequivalence study of two RGE (Remogliflozin etabonate) formulations in wistar rat plasma has been developed using Rosuvastatin as internal standard and validated as per ICH guidelines. The plasma samples were extracted with methanol and chromatographic separation was achieved on phenomenex C18 (250 x 4.6mm, 5μ) analytical column with a mobile phase of methanol: 0.2% TEA (pH adjusted to 3 with orthophosphoric acid) in the ratio of 78:22% v/v and detection at 227nm. Calibration curve was linear in the range of 100-600ng/ml and the r2 value was found to be 0.9906. The extraction efficiency of RGE from rat plasma at the concentration of 50, 100 and 150% was found to be 99.6%, 99.9% and 98.05%. The Intra-day precision and interday precision was found to be 0.14 - 0.777% and 0.0070% - 0.0572% respectively. The maximum concentration (Cmax) obtained for two brands ( selected brand 1 & 2) formulation are 57.04 and 51.99 ng/ml respectively. The half life (t1/2) of two brands are calculated as 1 h. Area under the curve AUC 0- t of brand 1 and brand 2 is calculated as 343.235 and 310.1775ng h/ml and AUC 0-∞ is calculated to be 465.3665 and 501.4235ng h/ml respectively. The present study shows no significant difference in pharmacokinetic parameters between two products so the two formulations are considered to be bioequivalent.