Simultaneous quantitation of acetylsalicylic acid and clopidogrel along with their metabolites in human plasma using liquid chromatography tandem mass spectrometry

Biomedical Chromatography

Volumn 30, Issue 3, 2016, Pages 466-473

  Chhonker, Yashpal S ^a,c   Pandey, Chandra P ^a,b   Chandasana, Hardik ^a,c   Laxman, Tulsankar Sachin ^a,c   Prasad, Yarra Durga ^a,c   Narain, V S ^b   Dikshit, Madhu ^a   Bhatta, Rabi S ^a,c  

^a CENTRAL DRUG RESEARCH INSTITUTE   (India)

^b KING GEORGE'S MEDICAL UNIVERSITY   (India)

^c ACADEMY OF SCIENTIFIC AND INNOVATIVE RESEARCH ACSIR   (India)

Author keywords

Acetylsalicylic acid; Clopidogrel; LC MS MS; Pharmacokinetics; Therapeutic drug monitoring

Indexed keywords

DISEASES; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; METABOLITES; PATIENT MONITORING; PATIENT TREATMENT; PLASMA (HUMAN); SALICYLIC ACID;

ACETYLSALICYLIC ACIDS; CLOPIDOGREL; HUMAN PLASMAS; LC-MS-MS; LC.MS/MS; LIQUID CHROMATOGRAPHY COUPLED WITH TANDEM MASS SPECTROMETRIES; LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; LIQUID CHROMATOGRAPHY/TANDEM MASS SPECTROMETRY; PLASMA CONCENTRATION; THERAPEUTIC DRUG MONITORING;

PHARMACOKINETICS;

ACETONITRILE; ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID PLUS CLOPIDOGREL; AMMONIUM ACETATE; CARBOXYLIC ACID; CLOPIDOGREL; DRUG METABOLITE; SALICYLIC ACID; TICLOPIDINE;

ACUTE CORONARY SYNDROME; ADULT; ARTICLE; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DRUG METABOLISM; DRUG MONITORING; DRUG STABILITY; FEMALE; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPH; MAJOR CLINICAL STUDY; MALE; MASS SPECTROMETER; MEASUREMENT ACCURACY; PH; PROCESS OPTIMIZATION; SENSITIVITY AND SPECIFICITY; STORAGE; TANDEM MASS SPECTROMETRY; ANALOGS AND DERIVATIVES; BLOOD; CHEMISTRY; LIQUID CHROMATOGRAPHY; METABOLISM; PROCEDURES; REPRODUCIBILITY;

ASPIRIN; CHROMATOGRAPHY, LIQUID; DRUG MONITORING; DRUG STABILITY; HUMANS; LIMIT OF DETECTION; REPRODUCIBILITY OF RESULTS; TANDEM MASS SPECTROMETRY; TICLOPIDINE;

EID: 84956582890     PISSN: 02693879     EISSN: 10990801     Source Type: Journal    
DOI: 10.1002/bmc.3573     Document Type: Article

References (36)

1. Altamura AC, Moro AR and Percudani M. Clinical pharmacokinetics of fluoxetine. Clinical Pharmacokinetics 1994; 26: 201-214.
2. ® in Korean healthy volunteers. Biomedical Chromatography 2008; 22: 590-595.
3. Delavenne X, Basset T, Zufferey P, Malouk N, Laporte S and Mismetti P. Ultra-performance LC MS/MS method for quantification of clopidogrel active metabolite. Journal of Separation Science 2010a; 33: 1968-1972.
4. Delavenne X, Mallouk N, Piot M, Mismetti P and Laporte S. Is there really a relationship between the plasma concentration of the active metabolite of clopidogrel and the results of platelet function tests? Journal of Thrombosis and Haemostasis 2010b; 8: 2334-2338.
5. Diener H-C, Ringleb PA and Savi P. Clopidogrel for the secondary prevention of stroke. Expert Opinion on Pharmacotherapy 2005; 6: 755-764.
6. El-Sadek ME-H, Moustafa SM, Kadi HO and Al-Hakami AMA. Determination of clopidogrel carboxylic acid in human plasma by LC-MS/MS. American Journal of Analytical Chemistry 2011; 2: 447-455.
7. Gent M, Beaumont D, Blanchard J, Bousser M, Coffman J, Easton J, Hampton J, Harker L, Janzon L and Kusmierek J. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet 1996; 348: 1329-1339.
8. Herbert J, Frehel D, Vallee E, Kieffer G, Gouy D, Berger Y, Necciari J, Defreyn G and Maffrand J. Clopidogrel, a novel antiplatelet and antithrombotic agent. Cardiovascular Drug Reviews 1993; 11: 180-198.
9. Karaźniewicz-Łada M, Danielak D, Tezyk A, Zaba C, Tuffal G and GŁówka F. HPLC-MS/MS method for the simultaneous determination of clopidogrel, its carboxylic acid metabolite and derivatized isomers of thiol metabolite in clinical samples. Journal of Chromatography B 2012; 911: 105-112.
10. Karaźniewicz-Łada M, Danielak D, Burchardt P, Kruszyna Ł, Komosa A, Lesiak M and GŁówka F. Clinical pharmacokinetics of clopidogrel and its metabolites in patients with cardiovascular diseases. Clinical Pharmacokinetics 2014; 53: 155-164.
11. Kim K, Park P, Hong S and Park J. The effect of CYP2C19 polymorphism on the pharmacokinetics and pharmacodynamics of clopidogrel: a possible mechanism for clopidogrel resistance. Clinical Pharmacology and Therapeutics 2008; 84: 236-242.
12. Levy G. Clinical pharmacokinetics of salicylates: a re-assessment. British Journal of Clinical Pharmacology 1980; 10: 285S-290S.
13. Li S, Liu G, Jia J, Liu Y, Pan C, Yu C, Cai Y and Ren J. Simultaneous determination of ten antiarrhythic drugs and a metabolite in human plasma by liquid chromatography-tandem mass spectrometry. Journal of Chromatography B 2007; 847: 174-181.
14. Mani H, Toennes SW, Linnemann B, Urbanek DA, Schwonberg J, Kauert GF and Lindhoff-Last E. Determination of clopidogrel main metabolite in plasma: a useful tool for monitoring therapy? Therapeutic Drug Monitoring 2008; 30: 84-89.
15. Matuszewski BK and Chavez-Eng CM. Matrix effect in quantitative LC/MS/MS analyses of biological fluids: a method for determination of finasteride in human plasma at picogram per milliliter concentrations. Analytical Chemistry 1998; 70: 882-889.
16. McMahon GP and Kelly MT. Determination of aspirin and salicylic acid in human plasma by column-switching liquid chromatography using on-line solid-phase extraction. Analytical Chemistry 1998; 70: 409-414.
17. Mullangi R, Sharma K and Srinivas NR. Review of HPLC methods and HPLC methods with mass spectrometric detection for direct determination of aspirin with its metabolite(s) in various biological matrices. Biomedical Chromatography 2012; 26: 906-941.
18. Peer CJ, Spencer SD, VanDenBerg DA, Pacanowski MA, Horenstein RB and Figg WD. A sensitive and rapid ultra HPLC-MS/MS method for the simultaneous detection of clopidogrel and its derivatized active thiol metabolite in human plasma. Journal of Chromatography B 2012; 880: 132-139.
19. Pereillo J-M, Maftouh M, Andrieu A, Uzabiaga M-F, Fedeli O, Savi P, Pascal M, Herbert J-M, Maffrand J-P and Picard C. Structure and stereochemistry of the active metabolite of clopidogrel. Drug Metabolism and Disposition 2002; 30: 1288-1295.
20. Pirker R, Huck C, Popp M and Bonn G. Simultaneous determination of gentisic, salicyluric and salicylic acid in human plasma using solid-phase extraction, liquid chromatography and electrospray ionization mass spectrometry. Journal of Chromatography B 2004; 809: 257-264.
21. Robinson A, Hillis J, Neal C and Leary A. The validation of a bioanalytical method for the determination of clopidogrel in human plasma. Journal of Chromatography B 2007; 848: 344-354.
22. Shaw L-H and Tsai T-H. Simultaneous determination and pharmacokinetics of protein unbound aspirin and salicylic acid in rat blood and brain by microdialysis: an application to herbal-drug interaction. Journal of Chromatography B 2012; 895: 31-38.
23. Shuldiner AR, O'Connell JR, Bliden KP, Gandhi A, Ryan K, Horenstein RB, Damcott CM, Pakyz R, Tantry US, Gibson Q, Pollin TI, Post W, Parsa A, Mitchell BD, Faraday N, Herzog W and Gurbel PA. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA, the Journal of the American Medical Association 2009; 302: 849-857.
24. Silvestro L, Gheorghe M, Iordachescu A, Ciuca V, Tudoroniu A, Savu SR and Tarcomnicu I. Development and validation of an HPLC-MS/MS method to quantify clopidogrel acyl glucuronide, clopidogrel acid metabolite, and clopidogrel in plasma samples avoiding analyte back-conversion. Analytical and Bioanalytical Chemistry 2011; 401: 1023-1034.
25. Singh SS, Sharma K, Barot D, Mohan PR and Lohray VB. Estimation of carboxylic acid metabolite of clopidogrel in Wistar rat plasma by HPLC and its application to a pharmacokinetic study. Journal of Chromatography B 2005; 821: 173-180.
26. Souri E, Jalalizadeh H, Kebriaee-Zadeh A, Shekarchi M and Dalvandi A. Validated HPLC method for determination of carboxylic acid metabolite of clopidogrel in human plasma and its application to a pharmacokinetic study. Biomedical Chromatography 2006; 20: 1309-1314.
27. Sweeny JM, Gorog DA and Fuster V. Antiplatelet drug 'resistance'. Part 1: mechanisms and clinical measurements. Nature Reviews Cardiology 2009; 6: 273-282.
28. Taylor PJ. Matrix effects: the Achilles heel of quantitative high-performance liquid chromatography-electrospray-tandem mass spectrometry. Clinical Biochemistry 2005; 38: 328-334.
29. Trenk D, Hochholzer W, Fromm MF, Chialda LE, Pahl A, Valina CM, Stratz C, Schmiebusch P, Bestehorn HP, Buttner HJ and Neumann FJ. Cytochrome P450 2C19 681G>A polymorphism and high on-clopidogrel platelet reactivity associated with adverse 1-year clinical outcome of elective percutaneous coronary intervention with drug-eluting or bare-metal stents. Journal of the American College of Cardiology 2008; 51: 1925-1934.
30. US Food and Drug Administration. Guidance for Industry-Bioanalytical Method Validation. Center for Drug Evaluation and Research, US Department for Health and Human Services: Silver Spring, MD, May 2001.
31. Van Eeckhaut A, Lanckmans K, Sarre S, Smolders I and Michotte Y. Validation of bioanalytical LC-MS/MS assays: evaluation of matrix effects. Journal of Chromatography B 2009; 877: 2198-2207.
32. Wiviott SD and Antman EM. Clopidogrel resistance a new chapter in a fast-moving story. Circulation 2004; 109: 3064-3067.
33. Yamamoto E, Takakuwa S, Kato T and Asakawa N. Sensitive determination of aspirin and its metabolites in plasma by LC-UV using on-line solid-phase extraction with methylcellulose-immobilized anion-exchange restricted access media. Journal of Chromatography B 2007; 846: 132-138.
34. Yang X, Liu S, Sun J, Liu X, Sun Y and He Z. UPLC for the determination of clopidogrel in dog plasma by tandem quadrupole MS: application to a pharmacokinetic study. Chromatographia 2009; 70: 259-263.
35. Zhang G, Terry AV and Bartlett MG. Liquid chromatography/tandem mass spectrometry method for the simultaneous determination of olanzapine, risperidone, 9-hydroxyrisperidone, clozapine, haloperidol and ziprasidone in rat plasma. Rapid Communications in Mass Spectrometry 2007; 21: 920-928.
36. Zhang Y, Mehrotra N, Budha NR, Christensen ML and Meibohm B. A tandem mass spectrometry assay for the simultaneous determination of acetaminophen, caffeine, phenytoin, ranitidine, and theophylline in small volume pediatric plasma specimens. Clinica Chimica Acta 2008; 398: 105-112.