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

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(trimethylsilyl)trifluoro-acetamide at 70 degrees C for 30 minutes, and chromatographic separation was conducted on a fused silica capillary (HP-5, 30 m length x 0.32 mm i.d., 0.25 mu m 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 mu g/mL. The developed method was successfully applied to analyze the lumefantrine content of marketed fixed-dose combination antimalarial finished pharmaceutical products. Copyright (c) 2015, Food and Drug Administration, Taiwan. Published by Elsevier Taiwan LLC. All rights reserved.