Development and validation of a LC-ESI-MS/MS method for simultaneous quantification of olmesartan and hydrochlothiazide in human K3 EDTA plasma and its application to pharmacokinetic biostudy

References

• Sada T, Mizuno M, Nippon YZ. Pharmacological profiles and clinical effects of olmesartan medoxomil, a novel angiotensin II receptor blocker. Folia pharmacologica Japonica 2004;124:257–69. Available online at: http://www.ncbi.nlm.nih.gov/pubmed/15467259, accessed 14 Oct 2013
   Google Scholar
• Verma PK, Kamboj VK, Ranjan S. Spectrophotometric estimation of Olmesartan medoxomil in tablet dosage form with stability studies. Int J Chem Tech Res 2010;2:1129–34
   Google Scholar
• Goswami D, Kumar A, Khuroo AH, et al. Pharmacokinetic estimation of Losartan, Losartan carboxylic acid and hydrochlorothiazide in human plasma by LC/MS/MS Validated method. Clin Res Regul Affairs 2008;25:235–58
   Google Scholar
• European Society of Hypertension-European Society of Cardiology Guidelines Committee. European Society of Hypertension-European Society of Cardiology Guidelines for the management of arterial hypertension. J Hypertens 2003;21:1011–53
   PubMed Web of Science ®Google Scholar
• Duran AM. Clinical practice guidelines on hypertension and antihypertensive agents in chronic kidney disease (CKD). Indian J Nephrol 2005;15(Suppl 1):S14–S22
   Google Scholar
• Chrysant SG, Weber MA, Wang AC, Hinman DJ. Evaluation of antihypertensive therapy with the combination of olmesartan medoxomil and hydrochlorothiazide. Am J Hypertens 2004;17:252–259
   PubMed Web of Science ®Google Scholar
• Greathouse M. Olmesartan medoxomil combined with hydrochlorothiazide for the treatment of hypertension. Vasc Health Risk Manage 2006;2:401–409
   PubMedGoogle Scholar
• 21-286 Benicar Pharmacology Review Part 2 Accessdata FDA. NDA#21,286. 2002. Available online at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-286_Benicar_pharmr_P2.pdf, accessed 14 Oct 2013
   Google Scholar
• Huang T, He Z, Yang B, et al. Simultaneous determination of captopril and hydrochlorothiazide in human plasma by reverse phase HPLC from linear gradient elution. J Pharm Biomed Anal 2006;41:644–8
   PubMed Web of Science ®Google Scholar
• Suchara EA, Carasek E. Use of addition calibration technique for determination of acetaminophen and hydrochlorothiazide in human urine by high-performance liquid chromatogarphy. J Chromatogr Sci 2008;46:804–8
   PubMed Web of Science ®Google Scholar
• Parekh SA, Pudage A, Joshi SS, et al. Simultaneous determination of hydrochlorothiazide, quinapril and quinaprilat in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B Anal Technol Biomed Life Sci 2008;873:59–69
   PubMed Web of Science ®Google Scholar
• Song M, Hang T, Zhao H, et al. Simultaneous determination of amiloride and hydrochlorothiazide in human plasma by liquid chromatography/tandem mass spectrometry with positive/negative ion-switching electrospray ionisation. Rapid Commun Mass Spectrom 2007;21:3427–34
   PubMed Web of Science ®Google Scholar
• Liu DY, Hu P, Matsushima N, et al. Quantitative determination of olmesartan in human plasma and urine by liquid chromatography coupled to tandem mass spectrometry. J Chromatogr B Anal Technol Biomed Life Sci 2007;856:190–7
   PubMed Web of Science ®Google Scholar
• Kreutz R, Bolbrinker J, Huber M. Pharmacokinetics of olmesartan medoxomil plus hydrochlorothiazide combination in healthy subjects. Clin Drug Invest 2006;26:29–34
   PubMed Web of Science ®Google Scholar
• Liu D, Jang J, Wang P, et al. Simultaneous quantitative determination of olmesartan and hydrochlorothiazide in human plasma and urine by liquid chromatography coupled to tandem mass spectrometry. J Chromatgr B 2010;878:743–8
   PubMed Web of Science ®Google Scholar
• Kumar A, Verma PRP, Monif T, et al. Challenges in bioanalytical method for simultaneous determination of olmesartan and hydrochlorothiazide in human plasma byliquid chromatography coupled to tandem mass spectrometry. J Liq Chrom Rel Technol 2012;35:59–78
   Web of Science ®Google Scholar
• Guidance for industry: bioanalytical method validation. Rockville, MD: U.S. Food and Drug Administration Center for Drug Evaluation and Research and Center for Veterinary Medicine. 2001
   Google Scholar
• Taylor PJ. Matrix effects: the Achilles hill of quantitative high performance chromatography –electro spray-tandem mass spectrometry. Clin Biochem 2005;38:328–34
   PubMed Web of Science ®Google Scholar
• Savoie N, Booth BP, Bradley T, et al. The 2nd calibration and validation group workshop on recent issues in Good Laboratory Practice in bioanalysis. Bioanalysis 2000;1:19–30
   Google Scholar
• Lambert WE, Meyer E, Leenheer APD, et al. Pharmacokinetics of acitretin. Acta Derm Venereol Suppl (Stockholm) 1994;186:122–123
   PubMedGoogle Scholar
• Shargel L, Wu-Pong S, Yu A. Applied biopharmaceutics and pharmacokinetics: bioavailability and bioequivalence, 5th edn. McGraw Hill: New York, 2005:161
   Google Scholar
• Burton M, Shaw L, Schentag J, Evans W. Applied pharmacokinetics and pharmacodynamics; Principles of therapeutics drug monitoring, 4th edn. Philadelphia, PA: Lippincott, William & Wilkins, 2005:8
   Google Scholar
• Schuirmann DJ. A comparison of the two one-sided test procedures and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657
   PubMedGoogle Scholar
• Chow CS, Liu JP. Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker, 1992
   Google Scholar
• Clinical Pharmacology and Biopharmaceutics_Accessdata FDA, Center for Drug Evaluation and Research, Application Number 21-286. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-286benicarbiopharmrp1.pdf
   Google Scholar
• ©2009 DrugLead US FDA & EMEA, Hydrochlorothiazide. Available from: http://www.druglead.com/cds/hydrochlorothiazide.html
   Google Scholar
• Dolan JW. Calibration curve, Part 5: Curve Weighting. LCGC Europe 2009;22:414--19
   Google Scholar