| 英文摘要 |
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 70C 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 mm 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 PlacketteBurman 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. |
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