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采用胶束液相色谱法测定人血浆及药物剂型中共同给药的埃索美拉唑、来氟米特和布洛芬的生物分析方法。

Bioanalytical method for the estimation of co-administered esomeprazole, leflunomide and ibuprofen in human plasma and in pharmaceutical dosage forms using micellar liquid chromatography.

作者信息

Talaat Wael

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Damnhour, Egypt.

出版信息

Biomed Chromatogr. 2017 May;31(5). doi: 10.1002/bmc.3865. Epub 2016 Nov 15.

Abstract

The present study represents a connection between basic science and clinical applied science through providing a bioanalytical method for the analysis of certain co-administered drugs used for the treatment of rheumatoid arthritis. The studied drugs are esomeprazole, leflunomide and ibuprofen. The proposed bioanalytical method is a simple reversed phase high performance liquid chromatographic method using micellar mobile phase. The method is conducted using a Shim-pack VP-ODS (150 mm × 4.6 mm ID) stainless steel column at ambient temperature with ultraviolet detection at 285 nm. The micellar mobile phase consisted of 0.1 m sodium dodecyl sulfate, 10% n-propanol, 0.3% triethylamine in 0.02 m orthophosphoric acid (pH 3.5) and is pumped at a flow rate of 1.0 mL/min. The calibration curve was rectilinear over the concentration range of 0.1-5.0, 0.5-10.0 and 1.0-20.0 μg/mL for esomeprazole, leflunomide and ibuprofen respectively. The proposed method was successfully applied to the analysis of these drugs in dosage forms. The method is extended to the in-vitro, in-vivo determination of these drugs in spiked and real human plasma samples.

摘要

本研究通过提供一种生物分析方法来分析某些用于治疗类风湿性关节炎的联合用药,从而建立了基础科学与临床应用科学之间的联系。所研究的药物为埃索美拉唑、来氟米特和布洛芬。所提出的生物分析方法是一种使用胶束流动相的简单反相高效液相色谱法。该方法在室温下使用Shim-pack VP-ODS(150 mm×4.6 mm内径)不锈钢柱,在285 nm处进行紫外检测。胶束流动相由0.1 m十二烷基硫酸钠、10%正丙醇、0.3%三乙胺溶于0.02 m正磷酸(pH 3.5)组成,以1.0 mL/min的流速泵送。埃索美拉唑、来氟米特和布洛芬的校准曲线分别在0.1 - 5.0、0.5 - 10.0和1.0 - 20.0 μg/mL的浓度范围内呈线性。所提出的方法已成功应用于这些药物剂型的分析。该方法扩展到了加标和实际人血浆样品中这些药物的体外、体内测定。

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