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High throughput LC-MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma.
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jun 15; 853(1-2):320-32.JC

Abstract

A selective and high throughput liquid chromatography/tandem mass spectrometry (LC-MS/MS) method has been developed and validated to separate, detect and simultaneously quantify lamivudine (3TC), stavudine (d4T) and nevirapine (NVP) in human plasma using metaxalone as internal standard (IS). After solid phase extraction (SPE), the analytes and the IS were chromatographed on a Symmetry C18 (150 mmx3.9 mm i.d., 5 microm particle size) column using 5 microL injection volume with a run time of 4.5 min. An isocratic mobile phase consisting of 0.5% glacial acetic acid in water:acetonitrile (20:80, v/v) was used to separate all these drugs. The precursor and product ions of these drugs were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring mode (MRM) without polarity switch. The method was validated over the range of 25-3000 ng/mL for 3TC, 20-2000 ng/mL for d4T and 50-5000 ng/mL for NVP. The absolute recoveries for analytes (>or=86%) and IS (98.12%) achieved from spiked plasma samples were consistent and reproducible. Inter-batch and intra-batch precision (%CV) across four validation runs (LLOQ, LQC, MQC and HQC) was less than 10. The accuracy determined at these levels was within +/-8% in terms of relative error. The method was successfully applied to a pivotal bioequivalence study of [60 (3TC)+12 (d4T)+100 (NVP)] mg dispersible tablets in 60 healthy human subjects under fasting condition.

Authors+Show Affiliations

Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380009, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17481969

Citation

Mistri, Hiren N., et al. "High Throughput LC-MS/MS Method for Simultaneous Quantification of Lamivudine, Stavudine and Nevirapine in Human Plasma." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 853, no. 1-2, 2007, pp. 320-32.
Mistri HN, Jangid AG, Pudage A, et al. High throughput LC-MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;853(1-2):320-32.
Mistri, H. N., Jangid, A. G., Pudage, A., Gomes, N., Sanyal, M., & Shrivastav, P. (2007). High throughput LC-MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 853(1-2), 320-32.
Mistri HN, et al. High Throughput LC-MS/MS Method for Simultaneous Quantification of Lamivudine, Stavudine and Nevirapine in Human Plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jun 15;853(1-2):320-32. PubMed PMID: 17481969.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High throughput LC-MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma. AU - Mistri,Hiren N, AU - Jangid,Arvind G, AU - Pudage,Ashutosh, AU - Gomes,Noel, AU - Sanyal,Mallika, AU - Shrivastav,Pranav, Y1 - 2007/04/08/ PY - 2006/12/21/received PY - 2007/01/30/revised PY - 2007/03/25/accepted PY - 2007/5/8/pubmed PY - 2007/8/31/medline PY - 2007/5/8/entrez SP - 320 EP - 32 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 853 IS - 1-2 N2 - A selective and high throughput liquid chromatography/tandem mass spectrometry (LC-MS/MS) method has been developed and validated to separate, detect and simultaneously quantify lamivudine (3TC), stavudine (d4T) and nevirapine (NVP) in human plasma using metaxalone as internal standard (IS). After solid phase extraction (SPE), the analytes and the IS were chromatographed on a Symmetry C18 (150 mmx3.9 mm i.d., 5 microm particle size) column using 5 microL injection volume with a run time of 4.5 min. An isocratic mobile phase consisting of 0.5% glacial acetic acid in water:acetonitrile (20:80, v/v) was used to separate all these drugs. The precursor and product ions of these drugs were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring mode (MRM) without polarity switch. The method was validated over the range of 25-3000 ng/mL for 3TC, 20-2000 ng/mL for d4T and 50-5000 ng/mL for NVP. The absolute recoveries for analytes (>or=86%) and IS (98.12%) achieved from spiked plasma samples were consistent and reproducible. Inter-batch and intra-batch precision (%CV) across four validation runs (LLOQ, LQC, MQC and HQC) was less than 10. The accuracy determined at these levels was within +/-8% in terms of relative error. The method was successfully applied to a pivotal bioequivalence study of [60 (3TC)+12 (d4T)+100 (NVP)] mg dispersible tablets in 60 healthy human subjects under fasting condition. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/17481969/High_throughput_LC_MS/MS_method_for_simultaneous_quantification_of_lamivudine_stavudine_and_nevirapine_in_human_plasma_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1570-0232(07)00268-1 DB - PRIME DP - Unbound Medicine ER -