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改进的 HPLC 法测定人血浆中的四种 PPIs,奥美拉唑、泮托拉唑、兰索拉唑和雷贝拉唑。

Improved HPLC method for determination of four PPIs, omeprazole, pantoprazole, lansoprazole and rabeprazole in human plasma.

机构信息

Department of Pharmacology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.

出版信息

J Pharm Pharm Sci. 2010;13(1):1-10. doi: 10.18433/j3gp4q.

DOI:10.18433/j3gp4q
PMID:20456825
Abstract

PURPOSE

To develop a simple and rapid HPLC method for measuring of four proton-pump inhibitors (PPIs), omeprazole (OPZ), pantoprazole (PPZ), lansoprazole (LPZ) and rabeprazole (RPZ) concentrations in human plasma.

METHODS

Following a single step liquid-liquid extraction analytes along with an internal standard (IS) were separated using an isocratic mobile phase of phosphate buffer (10 mM)/acetonitrile (53/47, v/v adjusted pH to 7.3 with triethylamine) at flow rate of 1 mL/min on reverse phase TRACER EXCEL 120 ODS-A column at room temperature.

RESULTS

Total analytical run time for selected PPIs was 10 min. The assays exhibited good linearity (r(2)>0.99) over the studied range of 20 to 2500 ng/mL for OPZ, 20 to 4000 ng/mL for PPZ, 20 to 3000 ng/mL for LPZ and 20 to 1500 ng/mL for RPZ. The recovery of method was equal or greater than 80% and lower limit of quantification (LLOQ) was 20 ng/mL for four PPIs. Coefficient of variation and error at all of the intra-day and inter-day assessment were less than 9.2% for all compounds.

CONCLUSIONS

The results indicated that this method is a simple, rapid, precise and accurate assay for determination of four PPIs concentrations in human plasma. This validated method is sensitive and reproducible enough to be used in pharmacokinetic studies and also is time- and cost-benefit when selected PPIs are desired to be analyzed.

摘要

目的

开发一种简单、快速的 HPLC 方法,用于测量人血浆中四种质子泵抑制剂(PPIs),即奥美拉唑(OPZ)、泮托拉唑(PPZ)、兰索拉唑(LPZ)和雷贝拉唑(RPZ)的浓度。

方法

采用一步液液萃取,以磷酸盐缓冲液(10 mM)/乙腈(53/47,v/v)为流动相,用三乙胺调节 pH 值至 7.3,在室温下于反相 TRACER EXCEL 120 ODS-A 柱上进行等度洗脱,分离分析物和内标(IS)。

结果

所选 PPIs 的总分析运行时间为 10 分钟。该测定法在 20 至 2500 ng/mL 范围内对 OPZ、20 至 4000 ng/mL 范围内对 PPZ、20 至 3000 ng/mL 范围内对 LPZ 和 20 至 1500 ng/mL 范围内对 RPZ 均表现出良好的线性关系(r(2)>0.99)。方法回收率均等于或大于 80%,四种 PPIs 的定量下限(LLOQ)均为 20 ng/mL。所有化合物的日内和日间评估的变异系数和误差均小于 9.2%。

结论

结果表明,该方法是一种简单、快速、准确、灵敏的测定人血浆中四种 PPIs 浓度的方法。该方法灵敏、重现性好,足以用于药代动力学研究,并且在需要分析选定的 PPIs 时具有时间和成本效益。

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