HPLC法测定盐酸丙酰左卡尼汀原料药及其制剂的含量和有关物质OACSCDCSTPCD
Determination of Content and Related Substances of Propionyl-L-carnitine Hydrochloride Raw Materials and Its Preparation by HPLC
目的:建立测定盐酸丙酰左卡尼汀原料药及其制剂含重和有关物质的方法.方法:采用高效液相色谱法测定3批盐酸丙酰左卡尼汀原料药及注射用制剂中主成分及杂质A、B、C的含量.色谱柱为Angilent Eclipse XDB-C18,流动相为0.006 mol·L-1辛烷磺酸钠溶液(pH3.0)-甲醇(95:5),流速为1.0 mL· min-1,柱温为30 ℃,检测波长为210 nm.结果:盐酸丙酰左卡尼汀色谱峰与杂质峰能完全分离,主成分检测浓度线性范围为…查看全部>>
OBJECTIVE: To develop a method for the determination of the content and related substances of Propionyl-L-carni-tine hydrochloride raw materials and ts preparation. METHODS: HPLC method was adopted for the contents of main components and impurity A, B and C in 3 batches of Propionyl-L-carnitine hydrochloride raw material and injections. The separation was performed on Agilent Eclipse XDB-G? Column with mobile phase consisted of 0.006 mol · L-1octanesulfonic …查看全部>>
张现涛;焦豪妍;沈小钟;索其良
广东省中药研究所创新药物研究中心,广州510520广东省中药研究所创新药物研究中心,广州510520广东省中药研究所创新药物研究中心,广州510520广东省中药研究所创新药物研究中心,广州510520
医药卫生
盐酸丙酰左卡尼汀原料药注射用制剂高效液相色谱法含量有关物质
Propionyl-L-carnitine hydrochloride Crude drug Preparation for injection HPLC Content Related substance
《中国药房》 2012 (21)
1992-1994,3
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