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

Abstract

Author(s): Ishpreet Kaur, Sharad Wakode and Harsharan Pal Singh

Objective: To develop and validate simple, sensitive, precise, rapid and cost effective method for determination of Canagliflozin in bulk and pharmaceutical formulations as per ICH Guidelines. Methods: A simple double beam UV Spectrophotometric method has been developed and validated with different parameters such as Linearity, Precision, Repeatability, Limit of Detection (LOD), Limit of Quantification (LOQ), Accuracy, Robustness and Ruggedness. Results: Canagliflozin in methanol shows maximum absorbance at 290 nm. Beer’s law was obeyed in the concentration range of 5-10 mcg mL- 1, 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%. Conclusion: The proposed method is precise, accurate and reproducible and can be used for routine analysis of Canagliflozin in bulk and pharmaceutical dosage form.