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用于测定药物制剂中对乙酰氨基酚、去氧肾上腺素和氯苯那敏的聚乙二醇柱

Poly(ethyleneglycol) column for the determination of acetaminophen, phenylephrine and chlorpheniramine in pharmaceutical formulations.

作者信息

García A, Rupérez F J, Marín A, de la Maza A, Barbas C

机构信息

Facultad de CC Experimentales y de la Salud, Universidad S Pablo-CEU Urbanización Montepríncipe, Ctra Boadilla del Monte, km 5,3-28668 Madrid, Spain.

出版信息

J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Mar 5;785(2):237-43. doi: 10.1016/s1570-0232(02)00904-2.

Abstract

New polar reversed-phase stationary phases in HPLC provide specific selectivities which can help to solve traditional chromatographic problems related to the development of chromatographic methods with widely different retention times for the sample components. One such case is the analysis of pharmaceutical formulations against the common cold. Acetaminophen, phenylephrine and chlorpheniramine, compounds with different polarities, are frequently associated in these drugs. An isocratic and rapid HPLC method for the simultaneous determination of the three compounds, acetaminophen, phenylephrine and chlorpheniramine, in capsules as pharmaceutical formulations, including the separation of impurities (4-aminophenol and 4-chloracetanilide) and excipients, has been developed and validated. The final chromatographic conditions employed a Supelco Discovery HS PEG column poly(ethyleneglycol) 15x0.46 cm, 5 microm. The mobile phase was 20 mM phosphate buffer, pH 7.0-acetonitrile (90:10, v/v) at a flow-rate of 1 ml/min. UV detection was performed at 215 nm for all the compounds except acetaminophen, which was measured at 310 nm. Validation parameters permit us to consider this method suitable.

摘要

高效液相色谱法中的新型极性反相固定相具有特定的选择性,有助于解决传统色谱问题,这些问题与为样品组分开发具有广泛不同保留时间的色谱方法有关。其中一个例子是对治疗普通感冒的药物制剂进行分析。对乙酰氨基酚、去氧肾上腺素和氯苯那敏,这三种极性不同的化合物,经常同时存在于这些药物中。本文开发并验证了一种等度快速高效液相色谱法,用于同时测定胶囊剂型药物制剂中的对乙酰氨基酚、去氧肾上腺素和氯苯那敏这三种化合物,包括杂质(4-氨基酚和4-氯乙酰苯胺)和辅料的分离。最终的色谱条件采用Supelco Discovery HS PEG柱(聚乙二醇,15×0.46 cm,5 µm)。流动相为20 mM磷酸盐缓冲液(pH 7.0)-乙腈(90:10,v/v),流速为1 ml/min。除对乙酰氨基酚在310 nm处检测外,所有化合物均在215 nm处进行紫外检测。验证参数表明该方法是合适的。

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