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用于测定血浆中拉西地平的高效液相色谱-放射免疫分析法的自动化与验证

Automation and validation of the high-performance liquid chromatographic-radioimmunoassay method for the determination of lacidipine in plasma.

作者信息

Braggio S, Sartori S, Angeri F, Pellegatti M

机构信息

Research Laboratories, Glaxo S.p.A., Verona, Italy.

出版信息

J Chromatogr B Biomed Appl. 1995 Jul 21;669(2):383-9. doi: 10.1016/0378-4347(95)00128-6.

Abstract

The automation and validation of the HPLC-radioimmunoassay (RIA) method for the determination of lacidipine are reported. The solid-phase extraction step was automated by the introduction of the ASPEC system. A two-column system was adopted for the HPLC purification. The RIA was converted from heterogeneous to homogeneous by the scintillation proximity assay system and automated using an automatic dilution system. All characteristics in terms of accuracy, precision, specificity, and linearity resulted similar to the manual version. The quantification limit was set to 40 pg/ml. The new version of the method increased the number of samples assayed per month two- to three-fold.

摘要

报道了用于测定拉西地平的高效液相色谱-放射免疫分析法(HPLC-RIA)的自动化及验证。通过引入ASPEC系统实现了固相萃取步骤的自动化。采用双柱系统进行HPLC纯化。利用闪烁接近分析法系统将放射免疫分析从非均相转换为均相,并使用自动稀释系统实现自动化。在准确性、精密度、特异性和线性方面的所有特性与手动版本相似。定量限设定为40 pg/ml。该方法的新版本使每月测定的样品数量增加了两到三倍。

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