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Journal of Pharmaceutics
Volume 2013, Article ID 437697, 8 pages
http://dx.doi.org/10.1155/2013/437697
Research Article

Quantification of Lumefantrine in Human Plasma Using LC-MS/MS and Its Application to a Bioequivalence Study

Analytical Chemistry Research Laboratory, Mithibai College of Arts, Chauhan Institute of Science & Amrutben Jivanlal College of Commerce & Economics, Vile Parle (W), Mumbai 400056, India

Received 27 May 2012; Accepted 18 July 2012

Academic Editor: Gunawan Indrayanto

Copyright © 2013 Satish G. Pingale and Kiran V. Mangaonkar. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

An analytical method based on protein precipitation has been developed and validated for analysis of lumefantrine in human plasma. Artesunate was used as an internal standard for lumefantrine. Inertsil ODS column provided chromatographic separation of analytes followed by detection with mass spectrometry. The method involves simple isocratic chromatographic condition and mass spectrometric detection in the positive ionization mode using an API-3000 system. The total run time was 2.5 minutes. The proposed method has been validated with linear range of 200–20000 ng/mL for lumefantrine. The intrarun and interrun precision values are within 6.66% and 5.56%, respectively, for lumefantrine at the lower limit of quantification level. The overall recovery for lumefantrine and artesunate was 93.16% and 91.05%, respectively. This validated method was used successfully for analysis of plasma samples from a bioequivalence study.