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] Journal article | | Title | High throughput LC-MS/MS method for simultaneous quantification of lamivudine, stavudine and nevirapine in human plasma. | | Author(s) | Mistri HN, Jangid AG, Pudage A, Gomes N, Sanyal M, Shrivastav P | | Institution | Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380009, India; Accutest Research Laboratory, Satellite, Ahmedabad 380015, India. | | Source | J Chromatogr B Analyt Technol Biomed Life Sci 2007 Apr 8. | | 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 (150mmx3.9mm i.d., 5mum particle size) column using 5muL injection volume with a run time of 4.5min. 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 25-3000ng/mL for 3TC, 20-2000ng/mL for d4T and 50-5000ng/mL for NVP. The absolute recoveries for analytes (>/=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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 17481969 |
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