Vol. 8, Issue 4 (2019)

Author(s):
Krishna Jadav and Rajashree Mashru

Abstract:
Risk profile and uncertainty approximation are two prime and important parameters that need to be accepted for the evolution of the pharmaceutical process to obtain reliable results. The ordinary method validation process needs to be extempore so, as to provide to a high level of assurance of method reliability to quantify the quality element of a drug product. Risk contour, combined standard uncertainty and expanded uncertainty in the analysis of Aripiprazole and Lamotrigine in the synthetic mixture were analysed by absorption correction method in this present research work. The cause-effect diagram was used to determine uncertainty parameters and to make it more accurate and precise method was validated in our laboratory as per the ICH guidelines. Whilst evaluate the results of validation, a calibration model was established by Levene’s test. In uncertainty, the major contribution is owing to sample concentration and mass of the sample. This present research work distinctly illustrates the application of the theoretical concept of calibration model tests, relative bias, risk analysis and uncertainty in the method used for analysis in drug invention activity.