e-journal

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

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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
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 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 ¼ 99.5%, relative standard deviation (RSD) ¼ 1.0%], linearity (¼0.9986), precision (intraday ¼ 96.1% of the label claim, RSD ¼ 0.9%; interday ¼ 96.3% label claim, RSD ¼ 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.

Keywords:
antimalaria gas chromatographic assay coupled to flame ionization detector lumefantrine N,O-bis(trimethyl-silyl)trifluoroacetamide derivatization quality by design

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Ketersediaan

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Informasi Detail

Judul Seri

j o u rnal of food and drug a n a l y s i s

No. Panggil

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Penerbit

: Elsevier Taiwan., 2015

Deskripsi Fisik

j o u rnal of food and drug a n a l y s i s 2 3 ( 2 0 1 5 ) 5 5 2 e5 5 9

Bahasa

English

ISBN/ISSN

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Klasifikasi

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Tipe Isi

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Tipe Media

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Tipe Pembawa

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Edisi

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Subjek

Food And Health

Info Detail Spesifik

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Pernyataan Tanggungjawab

Wati/Agus

Versi lain/terkait

Lampiran Berkas

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