Determination of vancomycin related substances by gradient high-performance liquid chromatography.
Determination of vancomycin related substances by gradient high-performance liquid chromatography.
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DOI：
10.1016/s0021-9673(00)90066-9
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发表时间：
1987
期刊：
影响因子：
--
通讯作者：
E. Inman
中科院分区：
文献类型：
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作者：
E. Inman
建立了测定万古霉素有关物质的梯度高效液相色谱法。开发该方法以分析万古霉素、共发酵产物和降解产物。所得色谱图证实了万古霉素的多因子性质，从主要组分中分离出许多峰。描述了可接受色谱性能的开发，最终方法预期用作对照试验。通过比较贮备液和25倍稀释液的一对色谱图中主峰与总峰面积的相对面积，定量测定总有关物质。使用快速扫描UV检测器证明万古霉素有关物质的相似光谱特征，证实了相对面积法的有效性。包括统计方法验证数据，评估该方法在定量应用中的使用。实例应用表明了该方法的有效性。
A gradient high-performance liquid chromatographic method for the determination of vancomycin related substances is described. This method was developed to profile vancomycin, co-fermentation products, and degradation products. The resultant chromatograms confirm the multifactored nature of vancomycin, separating a number of peaks from the main component. The development of acceptable chromatographic performance is described, with the final method intended for use as a control assay. Quantitation of total related substances is made by comparing the relative area of the main peak to total peak area in a pair of chromatograms from a stock solution and a twenty-five fold dilution. A rapid-scan UV detector was used to demonstrate the similar spectral characteristics of the vancomycin related substances, confirming the validity of the relative area approach. Statistical method validation data are included, evaluating the use of this method for quantitative applications. Example applications demonstrate the effectiveness of this method.