Abstract

A VALIDATED REVERSE PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF CANAGLIFLOZIN.

S. Sreenivasulu, M. Rameswara Rao* and K. B. ChandraSekhar

ABSTRACT

A simple reverse phase liquid chromatographic method with ultraviolet detector was developed for the accurate determination of Canagliflozin using Phenomenex Gemini-NX C18 Column (250×4.6 mm, 5 μm particle size). The mobile phase used for the determination was Acetonitrile: 1-octanesulphonic acid in a ratio of 70:30 v/v at a flow rate of 1 mL per min. 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 developed method was extensively validated with different parameters such as Linearity, Precision, Accuracy, Robustness, Ruggedness, Limit of Detection (LOD) and Limit of Quantification (LOQ) and proved to be robust. The validated method is definite, meticulous and reproducible and can be used for routine analysis of Canagliflozin in bulk form.

Keywords: Canagliflozin, C18 Column, Acetonitrile: 1-octanesulphonic acid (70:30%), UV detector 245 nm.