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LC–MS–MS Method for Simultaneous Analysis of Abacavir and Lamivudine in Human Plasma, and Its Application to a Bioequivalence Study

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Abstract

A rapid and sensitive LC–MS–MS method has been developed and validated for simultaneous analysis of abacavir (ABA) and lamivudine (LAM) in human plasma. The analytes were extracted from human plasma by SPE. Nelfinavir (NEL) and emtricitabine (EMT) were used as the internal standards for ABA and LAM, respectively. An RP18 column enabled chromatographic separation of the analytes. The method involves simple isocratic chromatography and MS detection in positive-ionization mode. Validation of the method showed response was a linear function of concentration in the ranges 100.0–7000.0 ng mL−1 for ABA and 80.0–5000.0 ng mL−1 for LAM. At the LOQ levels, inter-run and intra-run precision were within 5.80 and 3.51%, respectively, for ABA and within 4.68 and 3.16%, respectively, for LAM. Overall recovery for ABA and LAM was 59.32 and 105.18%, respectively. Total elution time was 2 min only, which enabled quantification of more than 200 plasma samples per day. This validated method was used successfully for analysis of plasma samples from a bioequivalence study.

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Authors and Affiliations

  1. Department of Chemistry, Ruia College, Mumbai University, Matunga, Mumbai, India

    Noel A. Gomes & Vikas V. Vaidya

  2. Accutest Research Laboratories (I) Pvt. Ltd, Khairane, Navi Mumbai, 400709, India

    Noel A. Gomes, Ashutosh M. Pudage, Santosh S. Joshi & Sagar A. Parekh

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  1. Noel A. Gomes
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  2. Ashutosh M. Pudage
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  3. Santosh S. Joshi
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  4. Vikas V. Vaidya
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  5. Sagar A. Parekh
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Correspondence to Noel A. Gomes.

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Gomes, N.A., Pudage, A.M., Joshi, S.S. et al. LC–MS–MS Method for Simultaneous Analysis of Abacavir and Lamivudine in Human Plasma, and Its Application to a Bioequivalence Study. Chroma 68, 541–550 (2008). https://doi.org/10.1365/s10337-008-0789-x

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  • DOI: https://doi.org/10.1365/s10337-008-0789-x

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