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通过间接光度色谱法测定药物基质中的草酸盐。

Determination of oxalate in pharmaceutical matrices by indirect photometric chromatography.

作者信息

Downey B P, Jenke D R

机构信息

Travenol Laboratories, Inc., Morton Grove, Illinois 60053.

出版信息

J Chromatogr Sci. 1987 Nov;25(11):519-24. doi: 10.1093/chromsci/25.11.519.

Abstract

An indirect photometric ion chromatography method is developed for the quantitation of oxalate in typical pharmaceutical matrices. The column/mobile phase conditions used represent a trade off between resolving power and sensitivity and results in an assay with a total analysis time of less than 9 minutes. Method response is linear between concentrations of 10 to 80 ppm oxalate. The limit of quantitation is roughly 5 ppm. Precision in the range of 30 to 80 ppm is better than 1.0% RSD of replicate injections, and the accuracy in a variety of matrices is 100 +/- 2%. The method is quite rugged and meets rigorous suitability requirements even after 500 injections. Although the assay can be used to quantitate citrate as well, the retention time is relatively long (20 minutes) and sensitivity is limited due to the broadness of the peak.

摘要

开发了一种间接光度离子色谱法用于定量分析典型药物基质中的草酸盐。所使用的色谱柱/流动相条件是在分离能力和灵敏度之间进行权衡,从而得到一种总分析时间少于9分钟的分析方法。方法响应在草酸盐浓度为10至80 ppm之间呈线性。定量限约为5 ppm。30至80 ppm范围内的精密度优于重复进样的1.0%相对标准偏差(RSD),并且在各种基质中的准确度为100±2%。该方法相当耐用,即使在500次进样后仍能满足严格的适用性要求。尽管该分析方法也可用于定量分析柠檬酸盐,但其保留时间相对较长(20分钟),且由于峰宽,灵敏度有限。

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