Development of Simple, Reliable, Rugged, Specific and Stability Indicating HPLC Methods for Quantification of Impurities in Canagliflozin

R. Suresh¹*, Dr. Satyavir Singh ², K. Subhash Chander Reddy^3
1Research Scholar, ²Department of Science, OPJS University, Churu, Rajasthan.
²Department of Science, OPJS University, Churu, Rajasthan.
³Director Honour lab R&D, Bonthapalli, Hyderabad, Telangana.

A  B  S  T  R A C T
The aim of present research work development of simple, reliable, rugged, specific and stability indicating HPLC methods for quantification of impurities in canagliflozin. The chromatographic separation was achieved on YMC Pack Pro C18,150 x 4.6 mm, 3µm or Equivalent column elucidation using Acetonitrile: Water (80:20 v/v) diluent with UV detection at 290 nm and flow rate was 0.8 ml/min. The column temperature was maintained at throughout the analysis 30ºC. Forced dégradation study was carried out under acidic, basic, oxidative, photolytic and thermal conditions. The developed method was validated with respect to specificity, linearity, accuracy, precision and robustness. It can be implemented for routine quality control analysis and stability indicating of Canagliflozin and it impurities.
Keywords: Canagliflozin, HPLC, Impurities, Validation, Stability indicating