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

Sultan Suleman ^a,b, Yannick Verheust ^c, Ann Dumoulin ^c,
Evelien Wynendaele ^a, Matthias D'Hondt ^a, Kirsten Vandercruyssen ^a,
Lieselotte Veryser ^a, Luc Duchateau ^d, Bart De Spiegeleer ^a,*

^a Drug Quality and Registration (DruQuaR) Group, Department of Pharmaceutical Analysis, Faculty of
Pharmaceutical Sciences, Ghent University, Ghent, Belgium
^b School of Pharmacy, Jimma University, Jimma, Ethiopia
^c Research Group EnBiChem, Ghent University, Kortrijk, Belgium
^d Department of Comparative Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium

 

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,Oebis(trimethylsilyl) trifluoro-acetamide at 70
℃ 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 Plackette−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 mg/mL. The developed method was successfully applied to analyze the lumefantrine content of marketed fixeddose combination antimalarial finished pharmaceutical products.