کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1199172 1493563 2014 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Development and validation of a liquid chromatographic method for the stability study of a pharmaceutical formulation containing voriconazole using cellulose tris(4-chloro-3-methylphenylcarbamate) as chiral selector and polar organic mobile phases
ترجمه فارسی عنوان
توسعه و اعتبار سنجی یک روش کروماتوگرافی مایع برای مطالعه پایداری یک فرمول دارویی حاوی ویریکونازول با استفاده از سلولز ترسی (4-کلرو-3-متیل فنیل کربامات) به عنوان گیرنده های کروی و مراحل قطبی آلی متحرک
کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
چکیده انگلیسی


• A LC method was developed for the separation of voriconazole and its enantiomer.
• The method was also selective for the other impurities of voriconazole.
• A full validation of the method was performed.
• The chiral stability of the 1% ophthalmic solution for 16 days was demonstrated.

SummaryThe ophthalmic solution of voriconazole, i.e. (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol, made from an injection formulation which also contains sulfobutylether-β-cyclodextrin sodium salt as an excipient (Vfend®), is used for the treatment of fungal keratitis. A liquid chromatographic (LC) method using polar organic mobile phase and cellulose tris(4-chloro-3-methylphenylcarbamate) coated on silica as chiral stationary phase was successfully developed to evaluate the chiral stability of the ophthalmic solution. The percentage of methanol (MeOH) in the mobile phase containing acetonitrile (ACN) as the main solvent significantly influenced the retention and resolution of voriconazole and its enantiomer ((2S,3R)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol). The optimized mobile phase consisted of ACN/MeOH/diethylamine/trifluoroacetic acid (80/20/0.1/0.1; v/v/v/v). The method was found to be selective not only regarding the enantiomer of voriconazole but also regarding the specified impurities described in the monograph from the European Pharmacopoeia. The LC method was then fully validated applying the strategy based on total measurement error and accuracy profiles. Under the selected conditions, the determination of 0.1% of voriconazole enantiomer could be performed. Finally, a stability study of the ophthalmic solution was conducted using the validated LC method.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Chromatography A - Volume 1363, 10 October 2014, Pages 178–182
نویسندگان
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