Abstract

VALIDATION OF A STABILITY-INDICATING REVERSE PHASE HPLC METHOD FOR DETERMINATION OF CANAGLIFLOZIN API

V. Rahul Krishna, S. Amuthalakshmi* and C. N. Nalini

Abstract

A new simple, rapid and sensitive RP-HPLC method has been developed for the determination of Canagliflozin Active Pharmaceutical Ingridient (API). The method employs X-bridze C18 column (150mm×4.6 mm, 5mm particle size) column for the chromatographic separation and orthophosphoric acid (0.1% w/v) : acetonitrile (60:40, v/v) was used as a mobile phase. Separation was completed within 10 min with a flow rate of 1 ml/min and detection was at 230 nm. The retention time of canagliflozin was found to be 8.70 min. The proposed method was found to have the linearity in the concentration range of range of 25-75 μg/ml. Linear regression coefficient was not less than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98- 102% of Canagliflozin. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH Guidelines and USP requirements. The method was found to have suitable application in routine laboratory analysis with high degree of accuracy and precision.

Keywords: Canagliflozin, RP-HPLC Estimation, Analytical Method Validation, API.