高效液相色谱法检测布比卡因脂质体注射液中5种有关物质  

Determination of five related substances in Bupivacaine Liposome Injection by high performance liquid chromatography

作　　者：李龙英 王艳娟 韩勇 李海燕 王若柳 朱倩颖 LI Longying;WANG Yanjuan;HAN Yong;LI Haiyan;WANG Ruoliu;ZHU Qianying(Zhejiang Sundoc Pharmaceutical Science and Tech.Co.,Ltd.,Hangzhou 310051,China)

机构地区：[1]浙江圣兆药物科技股份有限公司,杭州310051

出　　处：《化学分析计量》2025年第2期66-71,共6页Chemical Analysis And Meterage

摘　　要：建立高效液相色谱法测定布比卡因脂质体注射液中5种有关物质的含量。采用YMC-Triart C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相A为50 mmol/L磷酸盐缓冲液(p H值为7.5)-乙腈(体积比为65∶35),流动相B为50mmol/L磷酸盐缓冲液(p H值为7.5)-乙腈(体积比为35∶65),梯度洗脱,流量为1.0 m L/min,柱温为40℃,检测波长为240 nm。在拟定色谱条件下,杂质A、杂质B、杂质E、布比卡因氮氧化物与杂质F的质量浓度分别在0.548~5.477、0.551~5.511、0.557~5.572、0.542~5.423、0.055~0.552μg/m L内与色谱峰面积线性关系良好,相关系数均为0.999 9;检出限分别为4.69、80.53、83.58、39.78、3.31 ng/m L;样品加标平均回收率分别为101.8%、100.5%、100.7%、97.8%、100.5%;测定结果的相对标准偏差分别为0.8%、0.6%、0.9%、0.7%、0.0%(n=6)。该方法快速简单,准确可靠,可用于布比卡因脂质体注射液有关物质的质量控制。A high performance liquid chromatography method was established for the determination of five related substances in Bupivacaine Liposome Injection.An YMC-Triart C_(18)(250 mm×4.6 mm,5μm)chromatographic column was used,with 50 mmol/L PBS solution(pH 7.5)-acetonitrile(volume ratio of 65:35)as mobile phase A,and 50 mmol/L PBS solution(pH 7.5)-acetonitrile(volume ratio of 35:65)as mobile phase B for the gradient elution mode.The flow rate was 1.0 mL/min,the column temperature was 40℃and the detection wavelength was 240 nm.Under the chromatographic conditions,the mass concentrations of impurity A,impurity B,impurity E,bupivacaine nitrogen oxide and impurity F had good linear relationships with the chromatographic peak area in the ranges of 0.548-5.477,0.551-5.511,0.557-5.572,0.542-5.423 and 0.055-0.552μg/mL,respectively.The correlation coefficients were 0.9999.The limits of detection were 4.69,80.53,83.58,39.78,3.31 ng/mL,respectively.The average recoveries of spiked samples were 101.8%,100.5%,100.7%,97.8%and 100.5%,respectively.The relative standard deviations of determination results were 0.8%,0.6%,0.9%,0.7%,0.0%(n=6),respectively.The method is simply,convenient and accurate,which can be used to control the quality of bupivacaine liposome injection.

关 键 词：高效液相色谱法 布比卡因脂质体注射液 有关物质 方法学验证 

分 类 号：O657.7[理学—分析化学]