采用表面多孔颗粒的螺旋霉素质量控制改进型液相色谱法。
Improved liquid chromatographic method for quality control of spiramycin using superficially porous particles.
机构信息
KU Leuven, University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, B-3000 Leuven, Belgium.
KU Leuven, University of Leuven, Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, Herestraat 49, O&N2, PB 923, B-3000 Leuven, Belgium; Mekelle University, College of Health Sciences, Department of Pharmacy, P.O. Box 1871, Mekelle, Ethiopia.
出版信息
J Pharm Biomed Anal. 2018 Feb 5;149:57-65. doi: 10.1016/j.jpba.2017.10.041. Epub 2017 Oct 31.
This article describes the development and validation of a liquid chromatographic method for spiramycin using a column with superficially porous particles. Gradient elution was applied and the mobile phase consisted of phosphate buffer (0.2M; pH 8.3) - HO - acetonitrile in a ratio 10:60:30 (v/v/v) for mobile phase A and 10:30:60 (v/v/v) for mobile phase B. UV detection was performed at 232nm. Compared to previous methods, the analysis time was about two times faster and impurities were better separated. Furthermore, impurities which were present above 0.25% were characterized using liquid chromatography coupled with mass spectrometry (LC/MS).
本文描述了一种使用表面多孔颗粒柱的螺旋霉素的液相色谱法的开发和验证。采用梯度洗脱，流动相由磷酸盐缓冲液（0.2M；pH8.3）-HO-乙腈以 10:60:30（v/v/v）比为流动相 A 和 10:30:60（v/v/v）比为流动相 B 组成。UV 检测在 232nm 处进行。与以前的方法相比，分析时间大约快了两倍，杂质的分离效果更好。此外，使用液相色谱-质谱联用（LC/MS）对含量大于 0.25%的杂质进行了表征。
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