苯磺顺阿曲库铵注射液中1,5-戊二醇二丙烯酸酯含量的测定  

Determination of 1,5-Pentanediol Diacrylate in Cisatracurium Besylate Injection

作　　者：姚振 郑莹 陈青连 张英 徐全华 YAO Zhen;ZHENG Ying;CHEN Qing-lian;ZHANG Ying;XU Quan-hua(Hangzhou Ausia Biological Technology Company,LTD,Hangzhou 310018,China;Hangzhou Hongyou Pharma Co.Ltd.,Hangzhou 310018,China)

机构地区：[1]杭州澳亚生物技术股份有限公司,浙江杭州310018 [2]杭州泓友医药科技有限公司,浙江杭州310018

出　　处：《海峡药学》2022年第7期59-62,共4页Strait Pharmaceutical Journal

摘　　要：目的建立苯磺顺阿曲库铵注射液中基因毒性杂质1,5-戊二醇二丙烯酸酯含量的HPLC方法。方法采用YMC-Ultra HT Hydrosphere C 18色谱柱(100 mm×3.0 mm,2μm),以0.2%磷酸水溶液为流动相A,乙腈为流动相B,进行梯度洗脱,流速为每分钟0.6 mL,柱温为30℃,检测波长为210 nm,研究苯磺顺阿曲库铵注射液中1,5-戊二醇二丙烯酸酯的含量测定。结果苯磺顺阿曲库铵注射液中1,5-戊二醇二丙烯酸酯与相邻色谱峰能达到有效分离;1,5-戊二醇二丙烯酸酯浓度在0.02~0.40μg·mL^(-1)内线性良好,分析方法的回收率、重复性与中间精密度、溶液的稳定性、耐用性等均在标准的规定范围内。结论该定量方法准确、可靠、稳定,可用于苯磺顺阿曲库铵注射液中1,5-戊二醇二丙烯酸酯的含量测定。OBJECTIVE To develop the HPLC quantitative method for genotoxic impurity 1,5-pentanediol diacrylate in Cisatracurium Besylate Injection.METHODS YMC-Ultra HT Hydrosphere(100 mm×3.0 mm,2μm)column was used as mobile phase with a gradient of 0.2%phosphoric acid solution and acetonitrile.The flow rate was 0.6 mL per minute,the column temperature was 30℃,and the detection wavelength was 210 nm.It was quantitatively studied in the raw material of Cisatracurium Besylate Injection for the genotoxic impurities such as 1,5-pentanediol diacrylate.RESULTS They could be effectively separated for the 1,5-pentanediol dicrylate and adjacent peak;The calibration curve of 1,5-pentanediol diacrylate showed good linearity within the concentration range of 0.02-0.40μg·mL^(-1).All the validation parameters about the method including accuracy,repeatability and intermediate precision,solution stability and durability met the required acceptance of standard.CONCLUSION The method is accurate,reliable and stable,and it is suitable for the determination of 1,5-pentanediol diacrylate in Cisatracurium Besylate Injection.

关 键 词：苯磺顺阿曲库铵注射液 1 5-戊二醇二丙烯酸酯 基因毒性杂质 液相色谱 

分 类 号：R927[医药卫生—药学]