Development and validation of a rapid ultra-high performance liquid chromatography method for the assay of benzalkonium chloride using a quality-by-design approach
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- 作者：Rangan Mallik ; mallik.rangan@gmail.com" class="auth_mail" title="E-mail the corresponding author ; Srividya Raman ; Xiaoli Liang ; Adam W. Grobin ; Dilip Choudhury
- 关键词：Benzalkonium chloride ; Quality-by-Design (QbD) ; Ultra-high performance liquid chromatography (UHPLC)
- 刊名：Journal of Chromatography A
- 出版年：2015
- 出版时间：25 September 2015
- 年：2015
- 卷：1413
- 期：Complete
- 页码：22-32
- 全文大小：4118 K
文摘
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UHPLC method for the assay for benzalkonium chloride in preserved drug formulations.
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A Quality-by-Design (QbD) approach used for the method development.
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QbD approach assured minimal risk of method failure during validation and routine use.
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Method is >10 times faster and >80 times more sensitive than US pharmacopeia method.
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Validation confirmed method is precise, accurate and linear for preserved drug formulations.