Author(s): J. Dharuman, Dr. Rakeshkumar Jat and Dr. S. Mohan
Accuracy of an analytical method is ensured by appropriate method validation process. Guidelines laid by the regulatory bodies can be a general framework to assess the validity of a method. Since these guidelines provide marginal accuracy of analytical results, this study was aimed to test a recently evolved strategy that may render analytical method validation more accurate and trustworthy. The concentration range in which reliable analytical results can be obtained is proposed by a Bayesian probability study. Such study renders perfect information about the concentration range of the analyte which may produce accurate analytical results. In order to ensure the applicability of this approach, it was applied for the validation of a HPLC–UV assay method developed for the quantification of amlodipine and indapamide in human plasma. A comparative study between the newer approach and the standard method validation proved that the application of Bayesian analysis at the end of the validation process can produce significant improvement in the analytical results.