Sensitive and specific LC–ESI–MS/MS method for the determination of a styrylquinoline, BA011FZ041, a potent HIV anti-integrase agent, in rat plasma

Pruvost, Alain; Levi, M.C.; Zouhiri, Fatima; Menier, Isabelle; Bénech, Henri

doi:10.1016/j.jchromb.2006.11.038

Journal of Chromatography B

2007

DOI: 10.1016/j.jchromb.2006.11.038

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Sensitive and specific LC–ESI–MS/MS method for the determination of a styrylquinoline, BA011FZ041, a potent HIV anti-integrase agent, in rat plasma

Alain Pruvost

M.C. Levi²,

Fatima Zouhiri³

et al.

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Cited by 6 publications

(4 citation statements)

References 20 publications

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“…The nonlinear effects of the MS detector can no longer be compensated for even by an SIL-IS, which may lead to a nonlinear calibration curve. Due to this nature of MS, quadratic regression models are sometimes used to address the nonlinear response behavior. , …”

mentioning

confidence: 99%

Identifying, Evaluating, and Controlling Bioanalytical Risks Resulting from Nonuniform Matrix Ion Suppression/Enhancement and Nonlinear Liquid Chromatography−Mass Spectrometry Assay Response

Liu

Arnold

2010

Anal. Chem.

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Matrix ion suppression/enhancement is a well-observed and discussed phenomenon in electrospray ionization mass spectrometry. Nonuniform matrix ion suppression/enhancement across different types of samples in an analytical run is widely believed to be well compensated for by using a stable isotope-labeled internal standard (SIL-IS) in bioanalysis using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). Therefore, the risk of nonuniform matrix ion suppression/enhancement is usually deemed low when an SIL-IS is used. Here, we have identified, evaluated, and proposed solutions to control bioanalytical risks from nonuniform matrix ion suppression/enhancement even with an SIL-IS through a case study using omeprazole. Two lots of human blank urine were tested, and ion enhancement of about 500% for omeprazole was observed in one lot but not in the other. When a quadratic regression model had to be used, the assay failed the industry acceptance criteria due to unacceptable positive bias for the middle and high quality control (QC) samples. The failure was attributed to different extents of matrix ion enhancement between the standards (STDs) and QCs, which resulted in the misaligned results from the regression model. It was concluded that, for the same amount of drug, nonuniform ion enhancement for different types of samples (STD or QC) resulted in different ion intensities, therefore leading to different response behaviors (linear or nonlinear) at the mass spectrometer detector. A simplified mathematical model was used to evaluate the risk when unmatched response models occurred for different types of samples. A diagnostic factor Q (Q = X(ULOQ)(-A/B)) was proposed to monitor the risks, where X(ULOQ) is the upper limit of quantitation of the assay, A is the quadratic slope of the curve, and B is the linear slope of the curve. The potential maximum errors were estimated on the basis of the mathematical model for different scenarios, and Q values were given to control the risks under these conditions for bioanalysis using LC-MS/MS.

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mentioning

confidence: 99%

Identifying, Evaluating, and Controlling Bioanalytical Risks Resulting from Nonuniform Matrix Ion Suppression/Enhancement and Nonlinear Liquid Chromatography−Mass Spectrometry Assay Response

Liu

Arnold

2010

Anal. Chem.

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“…The standard curves of the same analyte could be linear or nonlinear when run at different time or on different systems. To account for such phenomenon, quite a few explanations were proposed including saturation at high concentration during ionization, , formation of dimer/multimer/cluster ions, , charge competition, and detector saturation. , In some cases, quadratic regression was employed to contemplate the nonlinearity. , Although quadratic fitting can extend the dynamic range, it was not generally accepted in many regulatory analyses due to the quantitative biases. Such bias occurs mainly because of the calibration curve being parabolic at very high concentrations, and the wrongfully asymptotic behavior was introduced into the final analytical results .…”

mentioning

confidence: 99%

“…18,21 In some cases, quadratic regression was employed to contemplate the nonlinearity. 22,23 Although quadratic fitting can extend the dynamic range, it was not generally accepted in many regulatory analyses due to the quantitative biases. Such bias occurs mainly because of the calibration curve being parabolic at very high concentrations, and the wrongfully asymptotic behavior was introduced into the final analytical results.…”

mentioning

confidence: 99%

Development, Validation, and Application of a New Method To Correct the Nonlinearity Problem in LC-MS/MS Quantification Using Stable Isotope-Labeled Internal Standards

Liu

Zhu²,

Zhong

et al. 2019

Anal. Chem.

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Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) has become an indispensable tool for bioanalysis. To quantify a small molecule with LC-MS/MS, a stable isotope-labeled analyte is routinely used as the internal standard. However, cross signal contributions between the analyte and its stable isotope labeled internal standard (SIL-IS) could cause problems when the signal response of the LC-MS/MS system is nonlinear. In the present work, we try to illustrate how the “cross talk” between the analyte and its SIL-IS may cause problems for a nonlinear system. We assume that the instrumental responses toward the analyte and its SIL-IS are the same. When the calibration curve is nonlinear, the addition of a SIL-IS would practically move the response of the analyte up along the parabolic line causing a change in the signal strength of the analyte (usually decrease). The more the SIL-IS is added, the larger change the analyte signal would become. Such a problem would only be corrected by making the calibration curve linear. To this end, we proposed a component equation (CE) as the calibration for nonlinearity correction. In this study, we contrasted the accuracy of CE with the common quantitative method using two drugs whose mass spectrometric responses are linear and nonlinear, respectively. The acceptable accuracy results demonstrated that the CE calibration was comparable with the regular quantitative SIL-IS method with a proper weighting factor and much better than that without weighting. Therefore, CE calibration may provide another reliable way for LC-MS/MS quantification.

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“…Therefore, a SIL‐IS is considered superior to a structural analog IS for LC/MS/MS assays, especially in regulated bioanalysis . Non‐linear standard curves are more often observed when using an analog IS . However, even with the use of an SIL‐IS, non‐linear standard curves are often observed.…”

mentioning

confidence: 99%

Systematic evaluation of the root cause of non‐linearity in liquid chromatography/tandem mass spectrometry bioanalytical assays and strategy to predict and extend the linear standard curve range

Yuan

Zhang

Jemal

et al. 2012

Rapid Comm Mass Spectrometry

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In this work, the root cause of the non-linear behavior of the standard curve when using a SIL-IS was investigated and identified. Based on the findings, an improved multiple SRM channels approach was proposed and successfully applied to obtain a linear dynamic range of five orders of magnitude for one test compound. This approach may work particularly well for LC/MS/MS bioanalytical assay of dried blood spot (DBS) samples, for which a direct dilution is cumbersome.

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Sensitive and specific LC–ESI–MS/MS method for the determination of a styrylquinoline, BA011FZ041, a potent HIV anti-integrase agent, in rat plasma

Cited by 6 publications

References 20 publications

Identifying, Evaluating, and Controlling Bioanalytical Risks Resulting from Nonuniform Matrix Ion Suppression/Enhancement and Nonlinear Liquid Chromatography−Mass Spectrometry Assay Response

Identifying, Evaluating, and Controlling Bioanalytical Risks Resulting from Nonuniform Matrix Ion Suppression/Enhancement and Nonlinear Liquid Chromatography−Mass Spectrometry Assay Response

Development, Validation, and Application of a New Method To Correct the Nonlinearity Problem in LC-MS/MS Quantification Using Stable Isotope-Labeled Internal Standards

Systematic evaluation of the root cause of non‐linearity in liquid chromatography/tandem mass spectrometry bioanalytical assays and strategy to predict and extend the linear standard curve range

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