Stability Indicating Bioanalytical Method Development and Validation for Estimation of Remogliflozin Etabonate by RP-HPLC in Human Plasma

Background

Remogliflozin etabonate belongs to the gliflozin class used for the treatment of type 2 diabetes mellitus and non-alcoholic steatohepatitis.

Objectives

The objective of the present study is to develop an accurate, precise and validated bioanalytical reverse phase high-performance liquid chromatographic method for the estimation of Remogliflozin etabonate in human plasma and to conduct stability studies by forced degradation.

Materials and Methods

The chromatographic analysis was performed at 224 nm on THERMO C (250×4.6 mm, 5 μm) column with a flow rate of 1 mL/min and a mixture of methanol-0.1 % acetic acid (80:20 v/v) used as a mobile phase. The method was validated with respect to linearity, accuracy, precision and robustness. In compliance with ICH guidelines, forced degradation studies were conducted in acidic/alkaline hydrolytic, peroxide and photolytic conditions.

Results

The proposed method was used for the determination of drugs in plasma. Retention time was found to be 4.4 min for REM. The method was found to be linear over the concentration range 5-13 μg/ mL. The correlation coefficient was determined to be 0.9992. The recovery of REM was more than 98% and % RSD was found to be less than 2%. LOD and LOQ were determined to be 0.13 and 0.42, respectively.

Conclusion

The developed RP-HPLC method was found to be linear, accurate, precise and robust, hence it could be successfully used for routine quantification and stability monitoring of drugs in biological samples.