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采用¹H核磁共振波谱法对注射剂中碘比醇进行定量分析。

Quantitative analysis of iobitridol in an injectable preparation by 1H NMR spectroscopy.

作者信息

Borioni Anna, Gostoli Gianluca, Bossù Elena, Sestili Isabella

机构信息

Istituto Superiore di Sanità, Dipartimento del Farmaco, Rome, Italy.

Istituto Superiore di Sanità, Dipartimento del Farmaco, Rome, Italy.

出版信息

J Pharm Biomed Anal. 2014 Jun;94:19-22. doi: 10.1016/j.jpba.2014.01.030. Epub 2014 Jan 30.

Abstract

Nuclear magnetic resonance spectroscopy was used for direct quantitative determination of iobitridol in an injectable formulation. The method was developed on a medium field strength magnet (400MHz) and validation was performed by assessing specificity, accuracy, precision, linearity, stability of samples and robustness. Validation data confirm that the method is highly appropriate for direct quantification of iobitridol in the final formulation. Moreover the method has a good potential for rapid screening analyses due to straightforward experimental setup and lack of any sample pretreatment.

摘要

核磁共振光谱法用于直接定量测定注射剂中的碘海醇。该方法是在中场强磁体(400MHz)上开发的,并通过评估特异性、准确性、精密度、线性、样品稳定性和稳健性进行了验证。验证数据证实该方法非常适合直接定量最终制剂中的碘海醇。此外,由于实验设置简单且无需任何样品预处理,该方法具有快速筛选分析的良好潜力。

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