Development and validation of a liquid chromatographic method for the analysis of capreomycin sulfate and its related substances

被引：9
|
作者：
Mallampati, Swapna [1 ]
Huang, Shan [1 ]
Ashenafi, Dunge [1 ]
Van Hemelrijck, Elise [1 ]
Hoogmartens, Jos [1 ]
Adams, Erwin [1 ]
机构：
[1] Katholieke Univ Leuven, Lab Pharmaceut Anal, O&N 2, B-3000 Louvain, Belgium
来源：
JOURNAL OF CHROMATOGRAPHY A | 2009年 / 1216卷 / 12期
关键词：
Capreomycin sulfate; Impurities; LC;
D O I：
10.1016/j.chroma.2009.01.031
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
A gradient LC method for the analysis of capreomycin sulfate and its related substances was developed. The chromatographic conditions include the use of a Hypersil base deactivated C-18 (250 mm x 4.6 mm, 5 mu m) column maintained at 25 degrees C, a mobile phase containing aceronitrile, phosphate buffer pH 2.3 and 0.025 M hexanesulfonate at a flow rate of 1.0 mL/min and UV detection performed at 268 nm. Good separation of the four active components of capreomycin and eleven unknown impurities was achieved. A system suitability test to check the quality of the separation is specified. The method shows good repeatability, linearity and robustness. (c) 2009 Elsevier B.V. All rights reserved.
引用
收藏
页码：2449 / 2455
页数：7
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