Menu

The validation of analytical method verifies that the characteristics of the method if they satisfy the requirements of the method

January 26, 2019 0 Comment

The validation of analytical method verifies that the characteristics of the method if they satisfy the requirements of the method. The proposed method was validated according to ICH guidelines for specificity, linearity, accuracy, and precision, and robustness. Specificity was carried out in which no interference of the excipients was observed at retention time of the analytical peak. Calibration curve was constructed by plotting concentration Vs plot area. It showed that there was a good linear relationship in the concentration range of 40% to 160% with > 0.999 as the value of correlation co-efficient. The accuracy of the method was studied by analyzing the drug solutions at 80%, 100% and120% concentration level. The mean percentage recovery was found to be 101.7% For precision the sample solution at working concentration was analyzed in replicate as per the method. The percentage relative standard deviation was found to be less than 1%. Robustness of the method shows no significant change in system suitability parameters and mean % assay at modifying chromatographic conditions from the original method