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.

A new sample preparation and separation combination for the precise, accurate, and simultaneous determination of uracil and dihydrouracil in human plasma by reversed‐phase HPLC

“…The calibration curves of U and HU2 in BSA were linear over the concentration ranges 2.5–160 and 5.0–320 ng/mL, respectively. The concentration span is more than 50 times, the calibration curves were calculated by weighted linear analysis . In the weighted regression model the regression line gives more realistic results.…”

“…For acceptable intra-and interassay values, the precision should not exceed 15% except at the LOQ, where it should not exceed 20%. The accuracy should be within ±15% of the nominal concentrations, except at the LOQ where RE% should be within ±20% [28,29].…”

Linear calibrations in chromatography: The incorrect use of ordinary least squares for determinations at low levels, and the need to redefine the limit of quantification with this regression model

“…In 1997 the Société Française des Sciences et Techniques Pharmaceutiques (SFSTP) published a guide on the validation of chromatographic bio-analytical methods proposing a new validation approach using "accuracy profiles" [39]. This approach considers that by taking into account tolerance intervals (i.e., intervals where the expected proportion of future results will fall with a predetermined β-expectation [40]), which contain both trueness and precision, better determination of LOQ values is achieved [2,3,14,16,28,33,37,[39][40][41][42][43][44][45]. Journal of Separation Science This article is protected by copyright.…”

Development and Validation of Uv Spectroscopic Methods for Simultaneous Estimation of Ofloxacin and Tinidazole in Pharmaceutical Dosage Form

“…INTRODUCTION [1][2][3][4][5][6][7] Chemically, Ofloxacin (Figure 1) is a racemate, (±)-9-fluro-2,3-dihydro-3-methyl-10- (…”