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LC-Tandem Mass Spectrometry Method for Quantification of Lumefantrine in Human Plasma and Its Application to Bioequivalence Study

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Abstract

A rapid, specific and robust assay based on protein precipitation and liquid chromatography-electrospray ionization tandem mass spectrometry (LC–ESI–MS–MS) has been developed and validated for the quantitative analysis of lumefantrine, an antimalarial drug, in human plasma using piperazine bis chloroquinoline as internal standard (ISTD). The precursor to product ion transitions of m/z 528.2 → 510.3 and m/z 409.2 → 205.1 were used to measure the analyte and the ISTD, respectively. Analysis was performed on C8 column (50 mm × 4.6 mm, 5 μm) with 10 mM ammonium acetate/acetonitrile/0.05% acetic acid (10/85/5, v/v) as mobile phase at a flow rate of 0.6 mL min−1. The assay exhibited a linear dynamic range of 0.21–25.05 μg mL−1. The RSD% of intra-day and inter-day assay was ≤15%. The application of this assay was demonstrated in a bioequivalence study and will be ideal for pharmacokinetic studies in pediatric population.

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Authors and Affiliations

  1. Metabolism and Pharmacokinetic Department, Ranbaxy Research Laboratory, Plot No # 20, Sector-18, Gurgaon, 122015, Haryana, India

    Vaneet Munjal, Nishant Paliwal, Brijesh Kumar Chaursia, Brijesh Varshney, Tausif Ahmed & Jyoti Paliwal

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  1. Vaneet Munjal
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  2. Nishant Paliwal
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  3. Brijesh Kumar Chaursia
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  4. Brijesh Varshney
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  5. Tausif Ahmed
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  6. Jyoti Paliwal
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Correspondence to Jyoti Paliwal.

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Munjal, V., Paliwal, N., Chaursia, B.K. et al. LC-Tandem Mass Spectrometry Method for Quantification of Lumefantrine in Human Plasma and Its Application to Bioequivalence Study. Chroma 71, 505–510 (2010). https://doi.org/10.1365/s10337-009-1446-8

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  • DOI: https://doi.org/10.1365/s10337-009-1446-8

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