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Rapid and simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography-tandem mass spectrometry: Application to a clinical herb-drug interaction study.
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jun 01; 852(1-2):534-44.JC

Abstract

Nifedipine (NIF), a calcium channel antagonist, is metabolized primarily by cytochrome P450 (CYP3A4) to dehydronifedipine (DNIF). As such, NIF is often used as a probe drug for determining CYP3A4 activity in human studies. A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method was developed and validated to simultaneously determine NIF and DNIF in human plasma using nitrendipine as the internal standard (IS). After extraction of the plasma samples by ether-n-hexane (3:1, v/v), NIF, DNIF and the IS were subjected to LC/MS/MS analysis using electro-spray ionization (ESI). Chromatographic separation was performed on a Hypersil BDS C(18) column (50 mm x 2.1 mm, i.d., 3 microm). The method had a chromatographic running time of approximately 2.5 min and linear calibration curves over the concentrations of 0.5-100 ng/mL for NIF and DNIF. The recoveries of the one-step liquid extraction method were 81.3-89.1% for NIF and 71.6-80.4% for DNIF. The lower limit of quantification (LLOQ) of the analytical method was 0.5 ng/mL for both analytes. The intra- and inter-day precision was less than 15% for all quality control samples at concentrations of 2, 10, and 50 ng/mL. The validated LC/MS/MS method has been successfully used to study pharmacokinetic interactions of NIF with the herbal antidepressant St. John's wort in healthy volunteers. These results indicated that the developed LC/MS/MS method was efficient with a significantly shorter running time (2.5 min) for NIF and DNIF compared to those methods previously reported in the literature. The presented LC/MS/MS method had acceptable accuracy, precision and sensitivity and was used in a clinical pharmacokinetic interaction study of NIF with St. John's wort, a known herbal inducer of CYP3A4. St. John's wort was shown to induce NIF metabolism with increased plasma concentrations of DNIF.

Authors+Show Affiliations

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Validation Study

Language

eng

PubMed ID

17339138

Citation

Wang, Xue-Ding, et al. "Rapid and Simultaneous Determination of Nifedipine and Dehydronifedipine in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry: Application to a Clinical Herb-drug Interaction Study." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 852, no. 1-2, 2007, pp. 534-44.
Wang XD, Li JL, Lu Y, et al. Rapid and simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography-tandem mass spectrometry: Application to a clinical herb-drug interaction study. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;852(1-2):534-44.
Wang, X. D., Li, J. L., Lu, Y., Chen, X., Huang, M., Chowbay, B., & Zhou, S. F. (2007). Rapid and simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography-tandem mass spectrometry: Application to a clinical herb-drug interaction study. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 852(1-2), 534-44.
Wang XD, et al. Rapid and Simultaneous Determination of Nifedipine and Dehydronifedipine in Human Plasma By Liquid Chromatography-tandem Mass Spectrometry: Application to a Clinical Herb-drug Interaction Study. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jun 1;852(1-2):534-44. PubMed PMID: 17339138.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rapid and simultaneous determination of nifedipine and dehydronifedipine in human plasma by liquid chromatography-tandem mass spectrometry: Application to a clinical herb-drug interaction study. AU - Wang,Xue-Ding, AU - Li,Jia-Li, AU - Lu,Yan, AU - Chen,Xiao, AU - Huang,Min, AU - Chowbay,Balram, AU - Zhou,Shu-Feng, Y1 - 2007/02/21/ PY - 2006/12/28/received PY - 2007/02/01/revised PY - 2007/02/09/accepted PY - 2007/3/7/pubmed PY - 2007/8/2/medline PY - 2007/3/7/entrez SP - 534 EP - 44 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 852 IS - 1-2 N2 - Nifedipine (NIF), a calcium channel antagonist, is metabolized primarily by cytochrome P450 (CYP3A4) to dehydronifedipine (DNIF). As such, NIF is often used as a probe drug for determining CYP3A4 activity in human studies. A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method was developed and validated to simultaneously determine NIF and DNIF in human plasma using nitrendipine as the internal standard (IS). After extraction of the plasma samples by ether-n-hexane (3:1, v/v), NIF, DNIF and the IS were subjected to LC/MS/MS analysis using electro-spray ionization (ESI). Chromatographic separation was performed on a Hypersil BDS C(18) column (50 mm x 2.1 mm, i.d., 3 microm). The method had a chromatographic running time of approximately 2.5 min and linear calibration curves over the concentrations of 0.5-100 ng/mL for NIF and DNIF. The recoveries of the one-step liquid extraction method were 81.3-89.1% for NIF and 71.6-80.4% for DNIF. The lower limit of quantification (LLOQ) of the analytical method was 0.5 ng/mL for both analytes. The intra- and inter-day precision was less than 15% for all quality control samples at concentrations of 2, 10, and 50 ng/mL. The validated LC/MS/MS method has been successfully used to study pharmacokinetic interactions of NIF with the herbal antidepressant St. John's wort in healthy volunteers. These results indicated that the developed LC/MS/MS method was efficient with a significantly shorter running time (2.5 min) for NIF and DNIF compared to those methods previously reported in the literature. The presented LC/MS/MS method had acceptable accuracy, precision and sensitivity and was used in a clinical pharmacokinetic interaction study of NIF with St. John's wort, a known herbal inducer of CYP3A4. St. John's wort was shown to induce NIF metabolism with increased plasma concentrations of DNIF. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/17339138/Rapid_and_simultaneous_determination_of_nifedipine_and_dehydronifedipine_in_human_plasma_by_liquid_chromatography_tandem_mass_spectrometry:_Application_to_a_clinical_herb_drug_interaction_study_ DB - PRIME DP - Unbound Medicine ER -