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

Submitted by webadmin on Tue, 10/18/2016 - 13:22
Pharmaceutical Methods,2016,7,1,63-69.
Published:January 2016
Type:Original Article

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

Ishpreet Kaur1*, Sharad Wakode2, Harsharan Pal Singh3

1Department of Quality Assurance, Delhi Institute of Pharmaceutical Sciences & Research, Pushp Vihar, New Delhi, INDIA.

2Department of Pharmaceutical Chemistry, Delhi Institute of Pharmaceutical Sciences & Research, Pushp Vihar, New Delhi, INDIA.

3Institute of Food Processing Technology, Conestoga College Institute of Advanced Learning, Kitchener, Ontario, CANADA.

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.

Primary and Secondary Package of Canagliflozin Tablet Dosage Form (INVOKANA®).