Process Evaluation·Standard Deliberation

Exploration of matrix effect in drug concentration detection in biological samples

  • LIU Fei-fei ,
  • WANG Yu-zhu
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  • Center of Drug Evaluation, National Medical Products Administration, Beijing 100076, China

Received date: 2024-03-15

  Online published: 2025-01-07

Abstract

In the process of drug development, the bioanalytical is required generally in pharmacokinetic studies. The accuracy, reliability, and scientificity of bioanalytical method validation are crucial, the investigation of matrix effects has become an important part of the validation system for bioanalytical methods. This article investigated related guidelines from ICH, NMPA, FDA and EMA, searching the related domestic and foreign literature on matrix effect, combining with the case study of matrix effect in actual review, to discuss the method of investigating the matrix effect in the methodological verification of drug concentration detection in unknown biological samples, to clarify the causes and solutions of matrix effect. So as to ensure the standardization of the methodological verification of drug concentration detection in unknown biological samples and the accuracy of the test results, to achieve the optimization of drug concentration detection methods for biological samples.

Cite this article

LIU Fei-fei , WANG Yu-zhu . Exploration of matrix effect in drug concentration detection in biological samples[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(11) : 1944 -1950 . DOI: 10.16155/j.0254-1793.2024-0174

References

[1] 段醒妹,张晔. 基质效应及其消除[J]. 赤峰学院学报,2008,24(4):17
DUAN XM, ZHANG Y. Matrix effect and its elimination[J]. J Chifeng Univ, 2008,24(4):17
[2] 李文魁,张杰,谢励诚,译. 《液相色谱-质谱(LC-MS)生物分析手册:最佳实践、实验方案及相关法规》[M]. 北京:科学出版社,2017:285
Translated by LI WK, ZHANG J,XIE LC. Handbook of LC-MC Bioanalysis: Best Practices, Experimental Protocols, and Regulations[M]. Beijing:Science Press, 2017:285
[3] LI WK, ZHANG J, TSE FL. Handbook of LC-MS Bioanalysis[M]. New York: John Wiley & Sons, 2013:369
[4] DU LH, WHIT RL. Reducing glycerophosphocholine lipid matrix interference effects in biological fluid assays by using high-turbulence liquid chromatography[J]. Rapid Commun Mass Spectrom, 2008, 22(21):3362
[5] FUREY A, MORIARTY M, BANE V, et al. Ion suppression: a critical review on causes, evaluation,prevention and applications [J]. Talanta,2013,115(10): 104
[6] LEVERENCE R, AVERY MJ, KAVETSKAIA O, et al. Signal suppression/enhancement in HPLC-ESI-MS/MS from concomitant medications[J]. Biomed Chromatogr, 2007, 21(11):1143
[7] MATUSZEWSKI BK, CONSTANZER ML, CHAVEZNG CM. Strategies for the assessment of matrix effect in quantitative bioan-alytical methods based on HPLC-MS/MS[J]. Anal Chem, 2003, 75(13):3019
[8] VISWANATHA AN, DIMOPOULOS J, KIRISITS C, et al. Computed tomography versus magnetic resonance imaging-based contouring in cervical cancer brachtherapy: results of a prospective trial and preliminary guidelines for standardized contours[J]. Int J Radiat Oncol Biol Phys, 2007, 68:491
[9] XIA YQ, JEMAL M. Phospholipids in liquid chromatography/mass spectrometry bioanalysis: comparison of three tandem mass spectrometric techniques for monitoring plasma phospholipids, the effect of mobile phase composition on phospholipids elution and the association of phospholipids with matrix effects[J]. Rapid Commun Mass Spectrom, 2009, 23:2125
[10] 刘晓云,陈笑艳,钟大放. 液相色谱-串联质谱生物分析方法的基质效应和对策[J]. 质谱学报, 2017, 38(4):388
LIU XY, CHEN XY, ZHONG DF. Matrix effects and countermeasure of liquid chromatography- tandem mass spectrometry in bioanalysis[J]. J Chin Mass Spectrom Soc, 2017, 38(4):388
[11] 冯晓杰,杜丽英,冯章英,等. LC-MS/MS法测定血药浓度的基质效应研究进展[J]. 中国新药杂志,2015,24(13): 1488
FENG XJ, DU LY, FENG ZY, et al. Research progress of matrix effect in determining blood concentration by LC-MS/MS[J]. Chin J New Drugs, 2015, 24(13): 1488
[12] FUREY A, MORIARTY M, BANE V, et al. Ion suppression: a critical review on causes, evaluation, prevention and applications[J]. Talanta, 2013, 115(115):104
[13] 王迪敏,孟繁华,刘金艳,等.LC-MS/MS 法测定兔血浆和组织中辣椒碱和二氢辣椒碱的浓度[J]. 中国新药杂志,2014,23(24):2866
WANG DM, MENG FH, LIU JY, et al. Determination of capsaicin(CAP) and dihydrocapsaicin(DHC) in rabbit plasma and tissue by LC-MS/MS method[J]. Chin J New Drugs, 2014,23(24):2866
[14] LINDEGARDH N, ANNERBERG A, WHITE NJ, et al. Development and validation of a liquid chromatographic-tandem mass pectrometric method for determination of piperaquine in plasma stable isotope labeled internal standard does not always compensate for matrix effects[J]. J Chromatogr B Analyt Technol Biomed Life Sci, 2008, 862(1-2):227
[15] VAN EECKHAUT A,LANCKMANS K,SARRE S,et al.Validation of bioanalytical LC-MS/MS assays: evaluation of matrix effects[J]. J Chromatogr B Analyt Technol Biomed Life Sci, 2009, 877(23): 2198
[16] ICH. Bioanalytical Method Validation and Study Sample Analysis M10[EB/OL]. (2022-05-24) [2024-09-06]. https://www. ich. org/page/multidisciplinary-guidelines
[17] 中华人民共和国药典2020年版.四部[S]. 2020: 119
ChP 2020. Vol Ⅳ[S]. 2020:119
[18] FDA. Bioanalytical Method Validation Guidance for Industry[EB/OL]. (2018-05) [2024-09-06]. https://www. fda. gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
[19] FDA. Analytical Procedures and Methods Validation for Drugs and Biologics[EB/OL]. (2015-07) [2024-09-06]. https://www. fda. gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
[20] EMA. Guideline on Validation of Bioanalytical Methods[EB/OL]. (2011-07-21) [2024-09-06]. https://www. ema. europa. eu/en/human-regulatory-overview/research-development/scientific-guidelines
[21] IBRAHIM J,UNDERHILL LH,TAYLOR JS, et al. Clinical response to eliglustat in treatment-naive patients with Gaucher disease type 1: post-hoc comparison to imiglucerase in a real- world setting[J]. Mol Genet Metab,2015, 114(2): 93
[22] 李丹, 黄建耿,杨丛莲, 等. LC-MS/MS法测定人血浆中氨氯地平浓度:改善色谱条件消除基质效应[J]. 药学学报, 2016, 51 (6): 1004
LI D, HUANG JG, YANG CL, et al. Quantification of amlodipine in human plasma by LC-MS/MS method: elimination of matrix effects by improving chromatographic conditions[J]. Acta Pharm Sin, 2016, 51 (6): 1004
[23] 张妍,宋媛媛, 宋文娅,等. 在高效液相色谱质谱联用检测血浆莎巴比星的基质效应影响因素[J]. 中国新药杂志,2016, 25(11):1241
ZHANG Y, SONG YY, SONG WY, et al. Factors influencing matrix effects of sabarubicin and its major metabolite in human plasma during liquid chromatography-tandem mass spectrometry analysis[J]. Chin J New Drugs, 2016, 25(11):1241
[24] GONZALEZ O, BLANCO ME, IRIARTE G, et al. Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect[J]. J Chromatogr A, 2014, 1353:10
[25] 姚梦侃, 马秉亮, 马越鸣. 生物样品液质联用分析中的基质效应研究概况[J]. 药物分析杂志,2012, 30(12):2436
YAO MK, MA BL, MA YM. Overview of the matrix effect in quantitative liquid chromatography/mass spectrometry analyses of biological samples [J]. Chin J Pharm Anal,2012, 30(12):2436
[26] 向平, 沈敏, 卓先义. 在液相色谱-质谱分析中的基质效应[J]. 分析测试学报,2009,28(6): 753
XIANG P, SHEN M, ZHUO XY. Matrix effects in liquid chromatographic-mass spectrometric analysis[J]. J Instrum Anal,2009,28(6): 753
[27] 白梦如,申潜,马志媛,等. LC-MS/MS法同时测定人乳汁中贝他斯汀和羟氯喹的浓度[J]. 中国药房,2024, 35(11):1363
BAI MR, SHEN Q, MA ZY, et al. Simultaneous determination of bepotastine and hydroxychloroquine concentrations in human breast milk by LC-MS/MS[J]. China Pharm, 2024, 35(11):1363-1368
[28] 刘富邦,张瑛,王继芬,等. 实时直接分析串联质谱法检验血液和尿液中12个苯二氮类药物[J]. 药物分析杂志,2024, 44(6):960
LIU FB, ZHANG Y, WANG JF, et al. Determination of 12 benzodiazepines in blood and urine by DART-MS/MS method[J]. Chin J Pharm Anal,2024, 44(6):960
[29] 王成龙,刘佳,徐振林,等. 超高效液相色谱-串联质谱法检测6种样品基质中百草枯农药残留[J]. 药物分析杂志,2022, 42(12):2155
WANG LC, LIU J, XU ZL, et al. HPLC-MS/MS method for the quantification of vildagliptin in human plasma and its application [J]. Chin J Pharm Anal,2022, 42(12):2155
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