Quantitative determination of salbutamol sulfate impurities using achiral supercritical fluid chromatography

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• 作者：Amandine Dispas^a ; ^{amandine.dispas@ulg.ac.be} ; Vincent Desfontaine^b ; Bertyl Andri^a ; Pierre Lebrun^a ; ^c ; Dorina Kotoni^d ; Adrian Clarke^d ; Davy Guillarme^b ; Philippe Hubert^a
• 关键词：Supercritical fluid chromatography (SFC) ; Quality by design (QbD) ; Impurity profiling ; Method validation ; Total error approach ; Salbutamol sulfate
• 刊名：Journal of Pharmaceutical and Biomedical Analysis
• 出版年：2017
• 出版时间：5 February 2017
• 年：2017
• 卷：134
• 期：Complete
• 页码：170-180
• 全文大小：1812 K
• 卷排序：134

文摘

SFC is an alternative to European Pharmacopeia method LC method for salbutamol sulfate impurities determination. Separation of salbutamol sulfate impurities was achieved in 7 min using SFC. Robust SFC method was optimized thanks to Design Space strategy. SFC method was successfully validated according to total error approach. SFC could be used for the quality control of salbutamol sulfate API.