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

Liu, Guowen; Ji, Qin; Arnold, Mark E.

doi:10.1021/ac1013018

Cited by 49 publications

(46 citation statements)

References 19 publications

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“…This maximum degree of quadratic can be expressed as: y = C − 0.0001378 × C 2 . By using the Q-factor proposed by Liu et al [34], which was defined as ULOQ × (−A/B), this maximum degree of quadratic response corresponds to a Q-factor of 0.138.…”

Section: What Happen When Quadratic Response Is Regressed As Linear (mentioning

confidence: 99%

Comparison of different linear calibration approaches for LC–MS bioanalysis

Tan

Awaiye

Jose

et al. 2012

Journal of Chromatography B

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Section: What Happen When Quadratic Response Is Regressed As Linear (mentioning

confidence: 99%

Comparison of different linear calibration approaches for LC–MS bioanalysis

Tan

Awaiye

Jose

et al. 2012

Journal of Chromatography B

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“…The specificity of the GLI was determined by screening six different batches of human blank plasma spiked with ATV-ULOQ. The sensitivity is determined by injection of six LLOQ samples from six different lots of human plasma by spiking the concentration of ATV-ULOQ [28][29][30][31][32].…”

Section: Matrix Effect Specificity and Sensitivitymentioning

confidence: 99%

Simultaneous Determination of Atorvastatin and Glimepiride by LC-MS/MS in Human Plasma and Its Application to a Pharmacokinetic Study

Kumar¹,

Reddy²,

Thriveni³

et al. 2012

AJAC

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The aim of the proposed research work was to develop and validate a simple, selective, high sensitive and high-throughput assay for the simultaneous estimation of Atorvastatin and Glimepiride in human plasma using liquid chromatography tandem mass spectrometry (LC-MS/MS). Atorvastatin-Glimepiride combines a competitive inhibitor of HMG-CoA reductase and a sulfonylurea anti-diabetic drug. The purpose of this study was to develop single method for Atorvastatin and Glimepiride in plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) that would result into a simultaneous estimation of Atorvastatin and Glimepiride avoiding acid-lactone inter conversions right from sample collections to analysis on the LC-MS/MS. Sample collection procedure optimized for Atorvastatin holds good for Glimepiride, hence resulting into a simultaneous estimation of Atorvastatin and Glimepiride. Liquid-liquid extraction and liquid chromatography coupled to positive ion mode tandem mass spectrometry was used to develop the method and was validated according to US FDA guidelines. The calibration curves for two analytes were linear (R2 ≥ 0.9950, n = 4) over the concentration range of 0.2 -30 ng/mL for Atorvastatin and 1 -250 ng/mL for Glimepiride. Mean extraction recoveries 80.34 ± 9.43 for Atorvastatin and 88.19 ± 7.13 for Glimepiride. Intra-and inter-run mean percent accuracy was between 85% -115% and percent imprecision was ≤15%. Stability studies revealed that Atorvastatin and Glimepiride were stable in plasma during bench top (10.5 h at room temperature), in Injector (47.5 h), at the end of three successive freeze and thaw cycles and long term at −65˚C ± 15˚C for 114 days. The method was successfully applied to the study of pharmacokinetics of Atorvastatin and Glimepiride in healthy volunteers. Simultaneous estimation of Atorvastatin and Glimepiride is cost effective, reduces analysis cycle time, enables effective utilization of resources and reduces bleeding burden on human volunteers.

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“…Liquid chromatography-tandem mass spectrometry (LC-MS/MS) in which low molecular weight analytes (<2 kD) are separated from each other and from the endogenous components by liquid chromatography and then detected by tandem mass spectrometry has been the technique of choice for the past two decades (1)(2)(3)(4)(5)(6). One of the important considerations during mass spectrometric detection is the presence of matrix effect, in which ionization of the analytes of interest can be affected by the presence of co-eluting interfering components present in the sample matrix (7)(8)(9)(10)(11)(12). Matrix effect, in the form of ion suppression, or in some cases, ion enhancement, is a well-recognized phenomenon that affects bioanalysis by LC-MS/MS.…”

Section: Introductionmentioning

confidence: 99%

“…Matrix effect, in the form of ion suppression, or in some cases, ion enhancement, is a well-recognized phenomenon that affects bioanalysis by LC-MS/MS. The matrix factor, on the other hand, is the quantitative measurement of the matrix effect, and different methodologies have been proposed to evaluate this parameter (8,(13)(14)(15)(16). The determination of matrix factor has become a routine part of bioanalytical method validation.…”

Section: Introductionmentioning

confidence: 99%

Utilizing Internal Standard Responses to Assess Risk on Reporting Bioanalytical Results from Hemolyzed Samples

Fung

Aubry

Allentoff

et al. 2015

AAPS J

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Abstract. Bioanalytical analysis of toxicokinetic and pharmacokinetic samples is an integral part of small molecule drugs development and liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been the technique of choice. One important consideration is the matrix effect, in which ionization of the analytes of interest is affected by the presence of co-eluting interfering components present in the sample matrix. Hemolysis, which results in additional endogenous components being released from the lysed red blood cells, may cause additional matrix interferences. The effects of the degree of hemolysis on the accuracy and precision of the method and the reported sample concentrations from hemolyzed study samples have drawn increasing attention in recent years, especially in cases where the sample concentrations are critical for pharmacokinetic calculation. Currently, there is no established procedure to objectively assess the risk of reporting potentially inaccurate bioanalytical results from hemolyzed study samples. In this work, we evaluated the effect of different degrees of hemolysis on the internal standard peak area, accuracy, and precision of the analyses of BMS-906024 and its metabolite, BMS-911557, in human plasma by LC-MS/MS. In addition, we proposed the strategy of using the peak area of the stable isotope-labeled internal standard (SIL-IS) from the LC-MS/MS measurement as the surrogate marker for risk assessment. Samples with peak areas outside of the pre-defined acceptance criteria, e.g., less than 50% or more than 150% of the average IS response in study samples, plasma standards, and QC samples when SIL-IS is used, are flagged out for further investigation.KEY WORDS: hemolyzed sample/haemolyzed sample; hyperlipemic sample; internal standard peak area/internal standard responses; LC-MS/MS; regulated bioanalysis; risk assessment.

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

Cited by 49 publications

References 19 publications

Comparison of different linear calibration approaches for LC–MS bioanalysis

Comparison of different linear calibration approaches for LC–MS bioanalysis

Simultaneous Determination of Atorvastatin and Glimepiride by LC-MS/MS in Human Plasma and Its Application to a Pharmacokinetic Study

Utilizing Internal Standard Responses to Assess Risk on Reporting Bioanalytical Results from Hemolyzed Samples

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