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首页> 外文期刊>Journal of liquid chromatography and related technologies >Application of the ICH guidelines in validation of a chromatographic method for CCK-4 fragment of cholecystokinin
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Application of the ICH guidelines in validation of a chromatographic method for CCK-4 fragment of cholecystokinin

机译：ICH指南在胆囊收缩素CCK-4片段色谱方法验证中的应用

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摘要

This paper describes a simple and rapid procedure for the quantitation of the CCK-4 fragment of cholecystokinin by reversed phase high-performance liquid chromatography (RP-HPLC). The eluent for suitable separation on a C-18 column as stationary phase, was a water/acetonitrile (70/30, v/v) mixture with 0.05 trifluoroacetic acid, pH 2; UV detection was set at 280 nm. The method was developed and validated according to the International Conference on Harmonization (ICH) guidelines. The results obtained in the validation process, indicate that the method is specific, linear, accurate (recovery mean = 100.2 ?3.0%), and reliable (precision= 1.21%). Limit of detection is established for 10.9 < mu >g/mL and limit of quantitation for 33.1 < mu >g/mL. In addition, the usefulness of the method, in order to evaluate the stability of the compound, was demonstrated.
机译：本文介绍了一种通过反相高效液相色谱（RP-HPLC）定量测定胆囊收缩素CCK-4片段的简单而快速的程序。为了在C-18色谱柱上作为固定相进行适当分离的洗脱液是水/乙腈（70/30，v / v）混合物，含0.05三氟乙酸，pH 2;紫外线检测设定在280 nm。该方法是根据国际协调会议（ICH）指南开发和验证的。验证过程中获得的结果表明，该方法具有特异性，线性，准确（回收​​率均值为100.2±3.0％）和可靠（精度为1.21％）。建立的检测限为10.9 g / mL，定量限为33.1 g / mL。另外，证明了该方法的有效性，以便评估化合物的稳定性。

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