Abstract
Aims: Canagliflozin and Metformin HCl is a new drug combination for the treatment of Diabetes Mellitus which is one of the oldest and lethal diseases of the mankind. Aim of the research work was to develop and validate novel, rapid, sensitive, specific, robust stability indicating analytical method for the simultaneous estimation of Canagliflozin and Metformin HCl in the pharmaceutical dosage form as fixed dose formulation.
 Study Design: Method development and validation was performed as recommended in ICH guideline “Validation of analytical procedures: Test and Methodology Q2(R1)”.
 Methodology: Method develop with chromatographic parameters as C18 column (250mm×4.6 mm, 5mm particle size), HPLC system with PDA detector and mobile phase contained a mixture of Phosphate Buffer pH 5.0 and Acetonitrile (60:40 v/v). The flow rate was set to 1ml/min with responses measured at 290 nm, injection volume was 20 µl, and run time of 15 mins.
 Results: The retention time of Metformin Hydrochloride and Canagliflozin was 5.4 min and 7.6 min respectively with resolution of 7.0. Linearity was established in the range of 10-30 µg/ml for Metformin Hydrochloride and 0.5-1.5 µg/ml for Canagliflozin with correlation coefficients more than 0.999. The percentage recoveries were between (98.62-101.22%) and (98.68-101.27%) for Metformin Hydrochloride and Canagliflozin respectively. Validation parameters were evaluated according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The forced degradation studies were performed by using HCl, NaOH, H2O2, thermal and UV radiation. The developed method was successfully applied for the quantification and hyphenated instrumental analysis.
 Conclusion: Significance of developed method is that it can be utilize for routine or unknown sample analysis of assay of Metformin HCl and Canagliflozin in pharmaceutical dosage form developed by various Pharmaceutical Industry.
Highlights
For the system suitability to pass few criteria were set according to which the theoretical plate for Metformin and Canagliflozin peak should not be less than 2000, a tailing factor should be between 0.8 to 2.0, % RSD of six replicate injection should not be more than 2.0 and resolution factor between two peaks should be more than 5.0
Based on above presented data it is clearly evident that retention time of Metformin HCl and Canagliflozin was 5.4 min and 7.6 min respectively with resolution of 7.0
Linearity was established in the range of 10-30 μg/ml for Metformin HCl and 0.5-1.5 μg/ml for Canagliflozin with correlation coefficients more than 0.999
Summary
The laboratory (working) standard of Canagliflozin and Metformin HCl were received as gift sample from M/s Zydus Cadila. Solvents like Water, methanol and Acetonitrile were HPLC grade and reagent such as Potassium dihydrogen phosphate and potassium hydroxide were of analytical grade
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