【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。更多还原

【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 method is simple,fast,accurate and reliable to control the quality of levobupivacaine hydrochloride.更多还原