HPLC-UV METHOD FOR THE ESTIMATION OF CEFTRIOXONE AND SULBACTAM- VALIDATED USING ACCURACY PROFILES

Title: HPLC-UV METHOD FOR THE ESTIMATION OF CEFTRIOXONE AND SULBACTAM- VALIDATED USING ACCURACY PROFILES

Author(s): J. Dharuman, Dr. Rakeshkumar Jat and Dr. S. Mohan

ABSTRACT

Generally, accuracy of an analytical procedure is ensured by suitable method validation process. Guidelines provided 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 ceftrioxone and  sulbactam 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.

Keywords: Reliability, Bayesian, Accuracy, Analysis, validation, statistics

Download PDF

Comments are closed.