Relative matrix effects: A step forward using standard line slopes and ANOVA analysis

One of the alternative methods to identify and study the matrix effect is by determination of “relative” matrix effect. In this experiment % coefficient of variance of standard line slopes are calculated. First, six standard lines are prepared from single plasma lot. In another experiment standard l...

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Main Author: Chinmoy Ghosh
Format: Article
Language:English
Published: Elsevier 2019-11-01
Series:Arabian Journal of Chemistry
Online Access:http://www.sciencedirect.com/science/article/pii/S1878535214002676
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author Chinmoy Ghosh
author_facet Chinmoy Ghosh
author_sort Chinmoy Ghosh
collection DOAJ
description One of the alternative methods to identify and study the matrix effect is by determination of “relative” matrix effect. In this experiment % coefficient of variance of standard line slopes are calculated. First, six standard lines are prepared from single plasma lot. In another experiment standard line slopes are compared from six different lots of plasma. All these standard curves are prepared by using three different types of IS (internal standard). From all these experiments it is observed that using SIL-IS (stable isotope labeled-internal standard) is one of the best approach in methods having matrix effects. Alternatively, analog IS is a cost effective approach. After comparing a large number of calibration curve slopes, it can be recommended that during every bioanalytical method validation, where the sample size is >50, scientist should perform the “relative” matrix effect experiment by standard line slope method. In selected cases, the precision of standard line slopes in six different lots of a biofluid was compared with precision values determined six times in a single lot. The results of these studies indicated that the variability of standard line slopes in different lots of a biofluid [precision of standard line slopes expressed as coefficient of variation, CV (%)] may serve as a good indicator of a relative matrix effect and, it is suggested, this precision value should not exceed 5% for the method to be considered reliable and free from the relative matrix effect liability. Keywords: Relative matrix effect, Bioanalysis, LC–ESI–MS/MS, Matrix effect, Pharmacokinetic, Method validation
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spelling doaj.art-3555cb466c2e4e44b2181078d26314052022-12-22T02:35:17ZengElsevierArabian Journal of Chemistry1878-53522019-11-0112713781386Relative matrix effects: A step forward using standard line slopes and ANOVA analysisChinmoy Ghosh0School of Studies in Chemistry, Jiwaji University, Gwalior, M.P., IndiaOne of the alternative methods to identify and study the matrix effect is by determination of “relative” matrix effect. In this experiment % coefficient of variance of standard line slopes are calculated. First, six standard lines are prepared from single plasma lot. In another experiment standard line slopes are compared from six different lots of plasma. All these standard curves are prepared by using three different types of IS (internal standard). From all these experiments it is observed that using SIL-IS (stable isotope labeled-internal standard) is one of the best approach in methods having matrix effects. Alternatively, analog IS is a cost effective approach. After comparing a large number of calibration curve slopes, it can be recommended that during every bioanalytical method validation, where the sample size is >50, scientist should perform the “relative” matrix effect experiment by standard line slope method. In selected cases, the precision of standard line slopes in six different lots of a biofluid was compared with precision values determined six times in a single lot. The results of these studies indicated that the variability of standard line slopes in different lots of a biofluid [precision of standard line slopes expressed as coefficient of variation, CV (%)] may serve as a good indicator of a relative matrix effect and, it is suggested, this precision value should not exceed 5% for the method to be considered reliable and free from the relative matrix effect liability. Keywords: Relative matrix effect, Bioanalysis, LC–ESI–MS/MS, Matrix effect, Pharmacokinetic, Method validationhttp://www.sciencedirect.com/science/article/pii/S1878535214002676
spellingShingle Chinmoy Ghosh
Relative matrix effects: A step forward using standard line slopes and ANOVA analysis
Arabian Journal of Chemistry
title Relative matrix effects: A step forward using standard line slopes and ANOVA analysis
title_full Relative matrix effects: A step forward using standard line slopes and ANOVA analysis
title_fullStr Relative matrix effects: A step forward using standard line slopes and ANOVA analysis
title_full_unstemmed Relative matrix effects: A step forward using standard line slopes and ANOVA analysis
title_short Relative matrix effects: A step forward using standard line slopes and ANOVA analysis
title_sort relative matrix effects a step forward using standard line slopes and anova analysis
url http://www.sciencedirect.com/science/article/pii/S1878535214002676
work_keys_str_mv AT chinmoyghosh relativematrixeffectsastepforwardusingstandardlineslopesandanovaanalysis