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用于测定复方制剂的经过验证的绿色高效液相色谱法:与报道的传统方法的比较。

Validated green high-performance liquid chromatographic methods for the determination of coformulated pharmaceuticals: a comparison with reported conventional methods.

作者信息

Elzanfaly Eman S, Hegazy Maha A, Saad Samah S, Salem Maissa Y, Abd El Fattah Laila E

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt.

出版信息

J Sep Sci. 2015 Mar;38(5):757-63. doi: 10.1002/jssc.201401151. Epub 2015 Jan 27.

DOI:10.1002/jssc.201401151
PMID:25545351
Abstract

The introduction of sustainable development concepts to analytical laboratories has recently gained interest, however, most conventional high-performance liquid chromatography methods do not consider either the effect of the used chemicals or the amount of produced waste on the environment. The aim of this work was to prove that conventional methods can be replaced by greener ones with the same analytical parameters. The suggested methods were designed so that they neither use nor produce harmful chemicals and produce minimum waste to be used in routine analysis without harming the environment. This was achieved by using green mobile phases and short run times. Four mixtures were chosen as models for this study; clidinium bromide/chlordiazepoxide hydrochloride, phenobarbitone/pipenzolate bromide, mebeverine hydrochloride/sulpiride, and chlorphenoxamine hydrochloride/caffeine/8-chlorotheophylline either in their bulk powder or in their dosage forms. The methods were validated with respect to linearity, precision, accuracy, system suitability, and robustness. The developed methods were compared to the reported conventional high-performance liquid chromatography methods regarding their greenness profile. The suggested methods were found to be greener and more time- and solvent-saving than the reported ones; hence they can be used for routine analysis of the studied mixtures without harming the environment.

摘要

可持续发展概念引入分析实验室最近受到了关注,然而,大多数传统的高效液相色谱方法既不考虑所用化学品的影响,也不考虑所产生废物对环境的影响。这项工作的目的是证明传统方法可以被具有相同分析参数的更环保方法所取代。所建议的方法设计得既不使用也不产生有害化学品,并且在不损害环境的情况下,在常规分析中产生最少的废物。这是通过使用绿色流动相和较短的运行时间来实现的。选择了四种混合物作为本研究的模型;溴化氯氮卓/盐酸氯氮卓、苯巴比妥/溴哌喷酯、盐酸美贝维林/舒必利,以及盐酸氯苯那敏/咖啡因/8-氯茶碱,它们可以是原料药粉末形式,也可以是剂型形式。对这些方法的线性、精密度、准确度、系统适用性和稳健性进行了验证。将所开发的方法与已报道的传统高效液相色谱方法在绿色度方面进行了比较。结果发现,所建议的方法比已报道的方法更环保,更节省时间和溶剂;因此,它们可用于所研究混合物的常规分析而不损害环境。

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