Crucial Importance of Evaluating Internal Standards (IS) Response and Troubleshooting in Effective LCMS Method Development, Validation and Sample Analysis

Cho, Seongeun Julia; Vinter, Stephen; Garofolo, Fabio

doi:10.4155/bio-2019-0245

Cited by 2 publications

(2 citation statements)

References 14 publications

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“…Several procedures have been recommended to facilitate a deep understanding of IS variability from scientific perspective [5,7,9,[11][12][13]. Those recommendations can be summarized into the following two major areas: classify the abnormal IS response variability into sporadic and systematic ones; investigate whether or not the IS response variability in Cs/QCs have the similar trend versus respective study samples.…”

Section: Identification Of Abnormal Is Response Variabilitymentioning

confidence: 99%

“…In some cases, excess variability can be encountered due to subject sample-specific reason(s), human error(s) and/or instrument malfunction [7][8][9][10]. In the past years, much discussion has taken place in the bioanalytical community on IS selection, IS employment in bioanalytical process, IS response monitoring, root cause of abnormal IS response and associated investigation, assessment of possible impact due to abnormal IS response, and remediation of impacted results due to abnormal IS response [9][10][11][12][13][14][15][16][17]. The requirements and recommendations on IS performance in bioanalysis have been well considered by various regulatory bodies.…”

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confidence: 99%

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Evaluation, Identification and Impact Assessment of Abnormal Internal Standard Response Variability in Regulated LC−MS Bioanalysis

Barkley

et al. 2020

Bioanalysis

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Internal standard (IS) plays an important role in LC−MS bioanalysis by compensating for the variability of the analyte of interest in bioanalytical workflow. Due to the complexity of biological sample compositions and bioanalytical processes, a certain level of IS response variability across a run or a study is anticipated. However, an extensive variability may raise doubts to the accuracy of the measured results and also suggest nonoptimal analytical method. In this current paper, recent publications and guidelines regarding IS response in LC−MS bioanalysis were thoroughly reviewed with focus on the evaluation, identification and impact assessment of ‘abnormal’ IS response variability. A systematic decision tree was proposed to facilitate investigation into abnormal IS response variability after each run.

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Section: Identification Of Abnormal Is Response Variabilitymentioning

confidence: 99%

mentioning

confidence: 99%

Evaluation, Identification and Impact Assessment of Abnormal Internal Standard Response Variability in Regulated LC−MS Bioanalysis

Barkley

et al. 2020

Bioanalysis

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Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma

et al. 2021

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In the current work, a simple, economical, accurate, and precise HPLC method with UV detection was developed to quantify Favipiravir (FVIR) in spiked human plasma using acyclovir (ACVR) as an internal standard in the COVID-19 pandemic time. Both FVIR and ACVR were well separated and resolved on the C18 column using the mobile phase blend of methanol:acetonitrile:20 mM phosphate buffer (pH 3.1) in an isocratic mode flow rate of 1 mL/min with a proportion of 30:10:60 %, v/v/v. The detector wavelength was set at 242 nm. Maximum recovery of FVIR and ACVR from plasma was obtained with dichloromethane (DCM) as extracting solvent. The calibration curve was found to be linear in the range of 3.1–60.0 µg/mL with regression coefficient (r2) = 0.9976. However, with acceptable r2, the calibration data’s heteroscedasticity was observed, which was further reduced using weighted linear regression with weighting factor 1/x. Finally, the method was validated concerning sensitivity, accuracy (Inter and Intraday’s % RE and RSD were 0.28, 0.65 and 1.00, 0.12 respectively), precision, recovery (89.99%, 89.09%, and 90.81% for LQC, MQC, and HQC, respectively), stability (% RSD for 30-day were 3.04 and 1.71 for LQC and HQC, respectively at −20 °C), and carry-over US-FDA guidance for Bioanalytical Method Validation for researchers in the COVID-19 pandemic crisis. Furthermore, there was no significant difference for selectivity when evaluated at LLOQ concentration of 3 µg/mL of FVIR and relative to the blank.

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Crucial Importance of Evaluating Internal Standards (IS) Response and Troubleshooting in Effective LCMS Method Development, Validation and Sample Analysis

Cited by 2 publications

References 14 publications

Evaluation, Identification and Impact Assessment of Abnormal Internal Standard Response Variability in Regulated LC−MS Bioanalysis

Evaluation, Identification and Impact Assessment of Abnormal Internal Standard Response Variability in Regulated LC−MS Bioanalysis

Development and Validation of a Method for Quantification of Favipiravir as COVID-19 Management in Spiked Human Plasma

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