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

Submitted by webadmin on Tue, 10/18/2016 - 16:30
Pharmaceutical Methods,2015,6,2,82-86.
Published:July 2015
Type:Original Article

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

Ishpreet Kaur1*, Sharad Wakode2 and 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.

3Department of Quality Assurance, AIMIL Pharmaceuticals (I) Limited, New Delhi, India.

Abstract:

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.

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