Development and Validation of UV-Visible Spectroscopic Methods for Simultaneous Estimation of Canagliflozin and Metformin in Pharmaceutical Formulation

摘要

Two simple, accurate, precise and rapid UV-Visible spectroscopic methods have been developed and validated for simultaneous estimation of Canagliflozin (Cana) and Metformin HC1 (Met) in pharmaceutical formulation. Method A was Absorbance correction UV spectroscopy while method B was First order derivative spectroscopy. Method A was based on measurement of absorbances at wavelengths 233 nm (λ max of Met) and 291 nm (λ max of Cana). In case of Method B, from the first order derivative overlain spectra wavelengths 243 nm (Zero absorbance of Cana) and 318 nm (Zero absorbance of Met) were selected for analysis. Analysis of marketed formulation was done by both the methods. The percentage drug contents were found to be 98.48 ± 0.83 and 100.76 ± 1.29 for Cana and Met respectively by method A. Similarly, by method B the percentage drug contents were found to be 97.94 ± 0.96 and 97.22 ± 1.15 for Cana and Met respectively. Both the developed methods were validated as per ICH guidelines Q2 (Rl) for linearity, range, accuracy and precision. Linearity of both the methods was found to be in a range of 0.75 - 4.5 ug/ml and 2.5-15 ug/ml for Cana and Met 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 Cana and Met in pharmaceutical formulation.