Volume 10, Issue 1, January 2020

Development and Validation of UV- Spectrophotometric Method for The Estimation of Canagliflozin and Metformin

Author(s): S. J. Parmar, B. A. Patel*, A. B. Patel and Abhishek. Pandey
Abstract: To develop and validate simple, sensitive, precise, rapid and cost effective method for determination of Canagliflozin and Metformin in synthetic mixture as per ICH Guidelines. For the First order derivative spectroscopy development, solvent used was in ratio of Methanol: Water (40:60 %) and wavelengths of MF at 240 nm (Zero absorbance of CF) and CF 319 nm (Zero absorbance of MF) were selected for analysis. Analysis of synthetic mixture was also done by same method. The percentage drug contents were found to be 99.48 ± 0.83 and 100.76 ± 1.29 for CF and MF respectively, the developed methods were validated as per ICH guidelines Q2 (R1) for linearity, range, accuracy and precision. Linearity of the methods was found to be in a range of 15 – 30 μg/ml and 4 – 12 μg/ml for CF and MF respectively. The accuracy of the methods was determined by recovery studies. The % of drugs recovered was found to be close 100, indicating accuracy of the method. Precision of the methods was estimated by repeatability and intermediate precision studies. The % RSD values were found to be less than 2, proving methods were precise. Therefore, the developed methods could be effectively used for routine quality control analysis in industry for simultaneous analysis of CF and MF in pharmaceutical formulation.
PAGES: 65-72  |  23 VIEWS  35 DOWNLOADS

How To Cite this Article:

S. J. Parmar, B. A. Patel*, A. B. Patel and Abhishek. Pandey. Development and Validation of UV- Spectrophotometric Method for The Estimation of Canagliflozin and Metformin. 2020; 10(1): 65-72.