Gas chromatographic method for the determination of lumefantrine in antimalarial finished pharmaceutical products

S. Suleman
Y. Verheust
A. Dumoulin
E. Wynendaele
M. D'Hondt
K. Vandercruyssen
L. Veryser
L. Duchateau
B. De Spiegeleer

Abstract

A simple method has been developed and validated for quantitative determination of lumefantrine in antimalarial finished pharmaceutical products using gas chromatography coupled to flame ionization detector. Lumefantrine was silylated with N,O-bis(trimethyl-silyl)trifluoro-acetamide at 70°C for 30 minutes, and chromatographic separation was conducted on a fused silica capillary (HP-5, 30 m length × 0.32 mm i.d., 0.25 μm film thickness) column. Evaluation of the method within analytical quality-by-design principles, including a central composite face-centered design for the sample derivatization process and Plackett-Burman robustness verification of the chromatographic conditions, indicated that the method has acceptable specificity toward excipients and degradants, accuracy [mean recovery = 99.5%, relative standard deviation (RSD) = 1.0%], linearity (=0.9986), precision (intraday = 96.1% of the label claim, RSD = 0.9%; interday = 96.3% label claim, RSD = 0.9%), and high sensitivity with detection limits of 0.01 μg/mL. The developed method was successfully applied to analyze the lumefantrine content of marketed fixed-dose combination antimalarial finished pharmaceutical products. © 2015, Food and Drug Administration, Taiwan.

ScienceDirect Link

10.1016/j.jfda.2015.03.004

Recommended Citation

Suleman, S.; Verheust, Y.; Dumoulin, A.; Wynendaele, E.; D'Hondt, M.; Vandercruyssen, K.; Veryser, L.; Duchateau, L.; and De Spiegeleer, B. (2015) "Gas chromatographic method for the determination of lumefantrine in antimalarial finished pharmaceutical products," Journal of Food and Drug Analysis: Vol. 23 : Iss. 3 , Article 20.
Available at: https://doi.org/10.1016/j.jfda.2015.03.004