HPLC法测定盐酸左布比卡因有关物质及对映体纯度  

Determination of Related Substances and Enantiomer Purity of Levobupivacaine Hydrochloride by HPLC

作　　者：符义刚[1] 李莉娥 李杰 胡先明[1] 

机构地区：[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

出　　处：《化学与生物工程》2011年第8期91-94,共4页Chemistry & Bioengineering

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。An assay method for the determination of related substances and enantiomer purity of levobupiva caine 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 method is simple, fast, accurate and reliable to control the quality of levobupivacaine hydrochloride.

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 

分 类 号：O657.72[理学—分析化学] R927.2[理学—化学]