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HPLC法测定盐酸左布比卡因有关物质及对映体纯度
引用本文:符义刚,李莉娥,李杰,胡先明.HPLC法测定盐酸左布比卡因有关物质及对映体纯度[J].化学与生物工程,2011,28(8):91-94.
作者姓名:符义刚  李莉娥  李杰  胡先明
作者单位:1. 武汉大学药学院,湖北武汉,430072
2. 宜昌人福药业有限责任公司,湖北宜昌,443005
摘    要:采用高效液相色谱法,以Dikma Platisil ODS柱测定盐酸左布比卡因有关物质,以研创MCDP手性柱测定盐酸左布比卡因对映体纯度.结果表明,盐酸左布比卡因与其中间体及降解产物之间分离良好;盐酸左布比卡因与其右旋对映体可完全分离(R>1.5).该方法快速简便、准确可靠,可用于盐酸左布比卡因的质量控制.

关 键 词:高效液相色谱法  盐酸左布比卡因  有关物质  对映体纯度

Determination of Related Substances and Enantiomer Purity of Levobupivacaine Hydrochloride by HPLC
FU Yi-gang,LI Li-e,LI Jie,HU Xian-ming.Determination of Related Substances and Enantiomer Purity of Levobupivacaine Hydrochloride by HPLC[J].Chemistry & Bioengineering,2011,28(8):91-94.
Authors:FU Yi-gang  LI Li-e  LI Jie  HU Xian-ming
Affiliation:FU Yi-gang1,LI Li-e2,LI Jie2,HU Xian-ming1(1.College of Pharmacy,Wuhan University,Wuhan 430072,China,2.Yichang Humanwell Pharmaceutical Co.Ltd.,Yichang 443005,China)
Abstract:An assay method for the determination of related substances and enantiomer purity of levobupivacaine hydrochloride was established.HPLC Method was used to determine related substances of levobupivacaine hydrochloride on a Dikma Platisil ODS column,while enantiomer purity was inspected on a MCDP chiral column.The results showed that perfect resolution had been achieved among bupivacaine hydrochloride,its related substances and degradated products.The resolution of the two enantiomers was greater than 1.5.The...
Keywords:HPLC  levobupivacaine hydrochloride  related substance  enantiomer purity  
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