کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
11027364 | 1666301 | 2019 | 25 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A new MS compatible HPLC-UV method for Teicoplanin drug substance and related impurities, part 1: Development and validation studies
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کلمات کلیدی
ESIAPIEMARSSRRTteicoplaninLC-UVLC–MS - LC-MSEuropean Medicine Agency - آژانس پزشکی اروپاValidation - اعتبار سنجیRetention time - زمان بازداریRelative retention time - زمان نگهداری نسبیRelated substances - مواد مربوطImpurities - ناخالصی هاComplex - کمپلکسelectrospray ionization - یونیزاسیون الکترو اسپری
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: A new MS compatible HPLC-UV method for Teicoplanin drug substance and related impurities, part 1: Development and validation studies A new MS compatible HPLC-UV method for Teicoplanin drug substance and related impurities, part 1: Development and validation studies](/preview/png/11027364.png)
چکیده انگلیسی
The separation conditions for Teicoplanin were set on a LiChrospher 100 RP-18 column under gradient elution with a mobile phase composed of ammonium formate 25âmM at pH 6.00 and ACN. The new method was shown equivalent in terms of selectivity to the one reported in the European Pharmacopoeia Teicoplanin monograph, and was validated according to ICH Q2 R1 guidelines for the drug substance assay. The new method offers similar performance to the compendial one but has the advantage of being fully compatible with MS and it can be proposed as a useful tool also for controlling the quality of Teicoplanin fermentation batches and the occurrence of potential impurities.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 162, 5 January 2019, Pages 185-191
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 162, 5 January 2019, Pages 185-191
نویسندگان
Giorgio Marrubini, Sara Tengattini, Raffaella Colombo, Davide Bianchi, Fulvio Carlotti, Serena Orlandini, Marco Terreni, Caterina Temporini, Gabriella Massolini,