Validation of a Reversed-Phase Liquid Chromatographic Method for the Determination of Metronidazole in Transparent Oil-Water-Gel Formulations

被引：0
|
作者：
Anne-Marie Frasey
Anne Boyer-Grand
Marie-Paule Pouget
Brigitte Vennat
Claire Lartigue
Marie-Joséphe Galmier Galmier
机构：
[1] UMR INSERM 484,
[2] Laboratoire de Chimie Analytique et de Spectrométrie de Masse,undefined
[3] Faculté de Pharmacie,undefined
[4] BP38,undefined
[5] 63001 Clermont-Ferrand Cedex,undefined
[6] France,undefined
[7] Laboratoire de Pharmacie Galénique et de Pharmacotechnie Industrielle Faculté de Pharmacie,undefined
[8] BP 38,undefined
[9] 63001 Clermont-Ferrand Cedex,undefined
[10] France,undefined
来源：
Microchimica Acta | 2004年 / 144卷
关键词：
Key words: Metronidazole; gel; HPLC; method validation.;
D O I：
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摘要：
A high performance liquid chromatographic (HPLC) method for the determination of metronidazole in new gel formulations was developed and validated according to the recommendations of the International Harmonization Conference. An adaptation of the method described for metronidazole determination in plasma has been used, and the step of extraction has been developed. The method was demonstrated to be linear over a range of 60–140% of nominal label claim, accurate (100.08±0.63%) and precise (0.67% for intra-assay and 1.68% for inter-assay). Single point calibration was chosen for analysis because of its simplicity and wide use in the pharmaceutical industry for content uniformity analysis.
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页码：171 / 176
页数：5
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