Development and Validation of Stability indicating UV Spectroscopic Method for Determination of Canagliflozin in Bulk and Pharmaceutical Dosage Form

Abstract

Objective: To develop and validate simple, definite, stability indicating UV spectroscopic method for determination of Canagliflozin in bulk and pharmaceutical formulations as per ICH Q2 R1 Guidelines. Methods: Canagliflozin was subjected to different stress conditions as per ICH guidelineQ1A (R2). A stability-indicating UV Spectrophotometric method has been developed for analysis of the drug in the presence of the degradation products and is validated with different parameters such as Linearity, Precision, Repeatability, Limit of Detection (LOD), Limit of Quantification (LOQ), Accuracy, Robustness and Ruggedness. It involved a 2-h study in which methanol and distilled water were used as solvents. Results: Canagliflozin in methanol shows maximum absorbance at 290 nm. Beer’s law was obeyed in the concentration range of 5-10 mcg/mL. The LOD and LOQ were found to be 0.084 mcg/ml and 0.255 mcg/ml respectively. A recovery of Canagliflozin in tablet formulation was observed in the range of 80.00-120.00%. Percentage assay of Canagliflozin tablets (INVOKANA®) was found to be more than 99%. Degradation of Canagliflozin was found to occur in acid, alkaline, hydrogen peroxide and photolytic conditions where as it was found to be thermally stable. The amount of degraded drug was calculated by taking absorbance at 290 nm. Conclusion: The proposed method is definite, meticulous, reproducible and can be used for routine analysis of Canagliflozin in bulk and pharmaceutical dosage form. Key words : Canagliflozin, Method development, Validation, Ultraviolet Spectroscopy, Forced degradation.