Preformulation and UV-Spectrophotometric Analytical Method Validation Studies for Assessment of Canagliflozin

Abstract

>The objectives of the present investigation were the physicochemical examination of canagliflozin to authenticate the drug’s characteristics and validation of straightforward and rapid ultraviolet-spectroscopy technique for evaluation of canagliflozin in phosphate buffer, pH 6.8. X-ray diffraction study revealed numerous peaks i.e. 11.41, 16.35, 16.5, 16.65, 18.53, 18.58, 19.55, 20.11, 20.46, 20.71, 21.62, 23.96, 24.17, 24.77, 26.5, 27.08, 27.68, 28.22, 28.73 and 32.6 at °2θ which demonstrated extremely crystalline character of drug. The regression equation for the standard plot was Y = 0.01957X + 0.036, and correlation coefficient was 0.9936. The method was found linear as indicated by correlation coefficient values of 0.9933, 0.9938, and 0.9943 for three consecutive standard plots. The average recovery of Canagliflozin was found to be 100.033% which was inside the prerequisite specification of the range 98 to 102%. The percentage relative standard deviation for repeatability, inter-day precision, intermediate precision, and robustness was less than 2%. The limit of detection (LoD) for Canagliflozin was 2.38 μg/mL, and the limit of quantitation was 7.24 μg/mL, which established the sensitivity of the UV-spectroscopy analytical method. In conclusion, the validation parameters like linearity, accuracy, repeatability, inter-day precision, intermediate precision, robustness, and sensitivity were found acceptable for the UV-spectroscopy analytical technique for analysis of Canagliflozin.