title: Reliability-targeted HPLC-UV method validation--a protocol enrichment perspective.
abstract: Method validation is important in analytical chemistry to obtain the reliability of an analytical method. Guidelines provided by the regulatory bodies can be used as a general framework to assess the validity of a method. Since these guidelines do not focus on the reliability of analytical results exclusively, this study was aimed to combine a few recently evolved strategies that may render analytical method validation more reliable and trustworthy. In this research, the analytical error function was determined by appropriate polynomial regression statistics that determine the range of analyte concentration that may lead to more accurate measurements by producing the least possible total error in the assay and can be regarded as a reliable weighting method. The reliability of the analytical results over a particular concentration range has been proposed by a Bayesian probability study. In order to ensure the applicability of this approach, it was applied for the validation of an HPLC-UV assay method dedicated to the quantification of cefepime and tazobactam in human plasma. A comparison between the newer approach and the usual method validation revealed that the application of analytical error function and Bayesian analysis at the end of the validation process can produce significant improvements in the analytical results.
authors.affiliation: Sastra University, Thanjavur, India.
authors.forename: Joghee Gowder
authors.initials: JG
authors.lastname: Dharuman
authors.forename: Mahalingam
authors.initials: M
authors.lastname: Vasudevan
mesh_terms: D001499:Bayes Theorem; D000077723:Cefepime; D002511:Cephalosporins / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D006801:Humans; D010397:Penicillanic Acid / Q000031:analogs & derivatives* / Q000097:blood; D015203:Reproducibility of Results; D019438:Ritonavir / Q000097:blood*; D013056:Spectrophotometry, Ultraviolet / Q000379:methods* / Q000592:standards; D000078142:Tazobactam
chemical_list: D002511:Cephalosporins; D000077723:Cefepime; D010397:Penicillanic Acid; D019438:Ritonavir; D000078142:Tazobactam
keywords: Bayesian reliability; Bayesian validation; Polynomial weighting; Results probability; Validation