A validated stability indicating RP-HPLC method for the quantification of Canagliflozin

Abstract

A simple, authentic and stability indicating high performance liquid chromatographic method for determination of Canagliflozin in bulk and pharmaceutical formulations was developed and validated as per ICH Q2 R1 Guidelines, A C18 Column (250mm length×4.6 mm diameter x 5 μm particle size) with a mobile phase consisting of Acetonitrile: 1-octanesulphonic acid in a ratio of 70:30 v/v was employed for the chromatographic study. A flow rate of 1.0 mL/min with an injection volume of 20 μL was selected for this study and the proposed method was validated with different parameters such as Linearity, Precision, Accuracy, Robustness, Ruggedness, Limit of Detection (LOD) and Limit of Quantification (LOQ). Canagliflozin was eluted at 3.4 ± 0.5 min and detected at 245 nm. The method is linear over the concentration range of 10-100 μg/mL with correlation co-efficient r = 0.9997. The plate count and tailing factor was found 5398 and 1.05 respectively. The LOD and LOQ were found to be 0.0170 μg/mL and 0.1705 μg/mL respectively. The percentage recovery was achieved in the range of 98-102%, which was within the acceptance criteria. Developed method was employed to determine the amount of Canagliflozinpresent in dosage form (Sulisent). The stabilityof the method was demonstrated by forced degradation studies of drug in which it was degraded under conditions of hydrolysis (acidic and alkaline), oxidation, photolytic and thermal stress as per ICH guideline Q1A (R2).