2Simmons R J. In Analytical Profiles of Drug Substances, Volume 1 [M]. Florey K Ed. New York: Academic Press Inc., 1972: 319-338.
3United States Pharmacopeia Convention. USP35[S]. Rockville: United States Pharmacopeia Convention, Inc., 2012.
4British Pharmacopoeia Commission. British Pharmacopoeia 2012, Volume 1 [S]. London: The Stationary Office, 2012.
5国家食品药品监督管理局,化学药物杂质研究的技术指导原则[M].2005.
6Ruta J, Boccard J, Cabooter D, et al. Method development for pharmaceutics: Some solutions for tuning selectivi in reversed phase and hydrophilic interaction liqu ty id chromatography[J]. JPharm BiomedAnal, 2012, 63:95-105.
7Holzgrabe U, Brinz D, Kopec S, et al. Why not using capillary electrophoresis in drug analysis?[J]. Electrophoresis, 2006, 27(12): 2283-2292.
8Scholl J P, DeZwaan J. Micellar electrokinetic chromatography as a generalized alternative to high- performance liquid chromatography for purity determination of a class of investigational antibacterial drugs[J]. J Chromatogr B Biomed Sci Appl, 1997, 695(1): 147-156.
9Jouyban A, Kenndler E. Impurity analysis of pharmaceuticals using capillary electromigration methods[J]. Electrophoresis, 2008, 29(17): 3531-3551.
10Kopec S, Holzgrabe U. Amino acids: Aspects of impurity profiling by means of CE[J]. Electrophoresis, 2007, 28(13): 2153-2167.
