New Stability Indicating LC Method for Novel Antidiabetic Drug Canagliflozin Hemihydrate Quantification; Development and Validation

Abstract

Introduction: The present research includes a new RP-HPLC method development and validation of Canagliflozin Hemihydrate (CANAG) a novel antidiabetic drug. The novel analytical method developed was employed for the quantification of CANAG in bulk drug and as an Active Pharmaceutical Ingredient (API) in tablet formulation. Methods: The present study utilized HPLC instrument (Shimadzu) comprises of ultraviolet detector and COSMICSIL 100 C18 (250 × 4.6 mm) 5 μm column. The mobile phase consists of acetonitrile: water (70:30%v/v) of pH 3.0±0.05 adjusted by addition of ortho-phosphoric acid. The chromatographic conditions were, flow rate 1 ml/min, run time 6.0 min, injection volume 20 μl and detection wavelength 282 nm at room temperature. The developed method was validated as per International Conference on Harmonization (ICH) guidelines for achieving robustness and accuracy. Forced degradation studies were carried out to prove the capability of the developed method to quantify the CANAG analyte response in presence of degraded products. Results: The presently developed novel analytical method possesses a shorter retention time 4.1 min. The results of validation parameters suggested that the presently developed method was robust and accurate since %RSD, theoretical plates and tailing factor values were within the limits of ICH guidelines. The predominant principle peak was observed in the chromatogram for CANAG without any interference from peaks of the degraded products. Conclusion: The present research study concluded that the developed analytical method for CANAG was novel, robust accurate and the principle peak of CANAG was not affected by presence of degraded and products. The same method can be employed for analysis of CANAG as a bulk drug and as API in formulation.