A novel LC-MS/MS method for simultaneous quantification of tenofovir and lamivudine in human plasma and its application to a pharmacokinetic study

Autor: Seshagiri Rao Jvln, Jaswanth Kumar Inamadugu, Laxminarayana Burugula, Murali K. Matta, Nageswara Rao Pilli
Rok vydání: 2012
Předmět:
Zdroj: Biomedical Chromatography. 26:1202-1209
ISSN: 0269-3879
DOI: 10.1002/bmc.2679
Popis: A new, rapid, sensitive and specific LC-MS/MS method has been developed and validated for the simultaneous quantification of tenofovir and lamivudine in human plasma using abacavir as an internal standard. An API-4000 LC-MS/MS with electrospray ionization was operated in multiple-reaction monitoring mode for the analysis. The analytes were extracted from plasma by solid-phase extraction technique using an Oasis HLB cartridge. The reconstituted samples were chromatographed on a Chromolith ROD speed C18 column using a mixture of 0.1% formic acid in water and acetonitrile (90:10 v/v) at a flow-rate of 1 mL/min. The method was validated as per the FDA guidelines. The calibration curves were found to be linear in the range of 5–600 ng/mL for tenofovir and 25– 4000 ng/mL for lamivudine. The intra- and inter-day precision and accuracy results were well within the acceptable limits. A run time of 2.8 min consumed for each sample made it possible to analyze more samples per day. The proposed assay method was found to be applicable to a pharmacokinetic study in human male volunteers. Copyright © 2012 John Wiley & Sons, Ltd.
Databáze: OpenAIRE