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采用快速液相色谱法对注射用药物进行杂质分析及过程检测。

Impurity profiling and in-process testing of drugs for injection by fast liquid chromatography.

作者信息

Rocheleau Marie-Josée, Larouche Elaine, Salamu Cristina, Curca Mihaela

机构信息

Omega Laboratories Ltd., 11177 Hamon, Montréal, QC H3M 3E4, Canada.

出版信息

J Pharm Anal. 2012 Oct;2(5):372-377. doi: 10.1016/j.jpha.2012.07.004. Epub 2012 Jul 24.

DOI:10.1016/j.jpha.2012.07.004
PMID:29403769
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5760775/
Abstract

Liquid chromatography (LC) is considered by many as a mature technique. Nonetheless, LC technology continues to evolve driven by the need for high-throughput and high-resolution analyses. Over the past several years, small particle size packing materials have been introduced by several column manufacturers to enable fast and efficient LC separations. Several examples of pharmaceutical analyses, including impurity profiling of taxanes and atracurium besylate, testing of peptides in injectable dosage form, using sub-2 μm column technology are presented in this paper, demonstrating some of the capabilities and limitations of the technology.

摘要

液相色谱法（LC）被许多人视为一种成熟的技术。尽管如此，由于对高通量和高分辨率分析的需求，LC技术仍在不断发展。在过去几年中，几家色谱柱制造商推出了小粒径填充材料，以实现快速高效的LC分离。本文介绍了几个药物分析的例子，包括紫杉烷和苯磺顺阿曲库铵的杂质分析、注射剂剂型中肽的检测，使用了亚2微米柱技术，展示了该技术的一些能力和局限性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/cd2fed477a81/fx00.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/8ff74f088489/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/6e184b34118a/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/6dc9bdec8abf/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/cd2fed477a81/fx00.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/8ff74f088489/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/6e184b34118a/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/6dc9bdec8abf/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f75/5760775/cd2fed477a81/fx00.jpg

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本文引用的文献

1
Current applications of liquid chromatography/mass spectrometry in pharmaceutical discovery after a decade of innovation.经过十年的创新，液相色谱/质谱在药物发现中的当前应用。
Annu Rev Anal Chem (Palo Alto Calif). 2008;1:357-96. doi: 10.1146/annurev.anchem.1.031207.112855.
2
Pharmaceutical applications on columns packed with sub-2 microm particles.在填充有小于2微米颗粒的色谱柱上的药物应用。
J Chromatogr Sci. 2008 Mar;46(3):199-208. doi: 10.1093/chromsci/46.3.199.
3
Method transfer for fast liquid chromatography in pharmaceutical analysis: application to short columns packed with small particle. Part II: gradient experiments.
药物分析中快速液相色谱的方法转移：应用于装填小颗粒的短柱。第二部分：梯度实验。
Eur J Pharm Biopharm. 2008 Feb;68(2):430-40. doi: 10.1016/j.ejpb.2007.06.018. Epub 2007 Jul 6.
4
Method transfer for fast liquid chromatography in pharmaceutical analysis: application to short columns packed with small particle. Part I: isocratic separation.药物分析中快速液相色谱的方法转移：应用于填充小颗粒的短柱。第一部分：等度分离。
Eur J Pharm Biopharm. 2007 Jun;66(3):475-82. doi: 10.1016/j.ejpb.2006.11.027. Epub 2006 Dec 13.
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Fast analysis in liquid chromatography using small particle size and high pressure.
J Sep Sci. 2006 Aug;29(12):1836-48. doi: 10.1002/jssc.200600189.
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Use of ultra-performance liquid chromatography in pharmaceutical development.超高效液相色谱法在药物研发中的应用。
J Chromatogr A. 2006 Jun 30;1119(1-2):140-6. doi: 10.1016/j.chroma.2006.02.052. Epub 2006 Mar 27.
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Evaluation of a silica-based monolithic column in the HPLC analysis of taxanes.
J Pharm Biomed Anal. 2003 Feb 5;31(1):191-6. doi: 10.1016/s0731-7085(02)00566-6.
8
Does ester hydrolysis change the in vitro degradation rate of cisatracurium and atracurium?酯水解会改变顺式阿曲库铵和阿曲库铵的体外降解速率吗？
Br J Anaesth. 2002 Apr;88(4):555-62. doi: 10.1093/bja/88.4.555.
9
Structure, conformation, and action of neuromuscular blocking drugs.
Br J Anaesth. 2001 Nov;87(5):755-69. doi: 10.1093/bja/87.5.755.
10
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Anesthesiology. 1995 May;82(5):1131-8. doi: 10.1097/00000542-199505000-00007.