硫酸庆大霉素注射液C组分含量测定方法的改进  

Improvement of the method for the determination of the component C in Gentamycin sulfate injection

作　　者：张富东[1] 余敏灵 袁茂华 朱敏凤[2] 王丽琼 肖凤 ZHANG Fudong;YU Minling;YUAN Maohua;ZHU Minfeng;WANG Liqiong;XIAO Feng(Leshan Vocational and Technical College,Leshan,Sichuan,614000 P.R.China;SCMPA Key Laboratory of Quality Research of Traditional Chinese Medicine(TCM),Leshan Food and Drug Inspection Center,Leshan,Sichuan,614000 P.R.China;Key Laboratory of Standardization of TCM,State Key Laboratory Breeding Base of Systematic Research,Development and Utilization of Chinese Medicine Resources,School of Pharmacy,Chengdu University of TCM,Chengdu,Sichuan,611137 P.R.China;Sichuan Changzheng Pharmaceutical Co.,Ltd.,Leshan,Sichuan,614000 P.R.China)

机构地区：[1]乐山职业技术学院,四川乐山614000 [2]乐山市食品药品检验检测中心四川省药品监督管理局中药质量研究重点实验室,四川乐山614000 [3]成都中医药大学药学院中药材标准化重点实验室中药资源系统研究与开发利用省部共建国家重点实验室培育基地,四川成都611137 [4]四川省长征药业股份有限公司,四川乐山614000

出　　处：《华西药学杂志》2023年第4期416-418,共3页West China Journal of Pharmaceutical Sciences

基　　金：四川药品监督管理局科技计划项目(2021012);四川省市场监管系统科技计划项目(SCSJZ2022016)。

摘　　要：目的改进传统分析方法,采用以乙醇为流动相有机相的HPLC法测定硫酸庆大霉素注射液C组分的含量。方法采用Welch Ultimate C18色谱柱(250 mm×4.6 mm,5μm),流速0.7 mL·min^(-1),流动相为0.2 mol·L^(-1)三氟乙酸溶液-乙醇(96∶4),柱温40℃,蒸发光散射检测器的漂移管温度50℃,载气压力为350 kPa。结果硫酸庆大霉素C1、C1a、C2、C2a的线性范围分别为0.1725~0.8503、0.1649~0.8129、0.1834~0.9038、0.1118~0.5508 mg·mL^(-1)(r≥0.9998),平均回收率为99.80%~100.18%,RSD为0.36%~1.03%(n=6)。结论乙醇与蒸发光检测器有良好兼容性,适用于硫酸庆大霉素注射液C组分的含量测定。所用方法安全、环保,结果准确,建议推广使用。OBJECTIVE To establish an HPLC method using ethanol-water as the elution system for the determination of the component C in Gentamycin sulphate injection.METHODS The determination was performed on WeLch ULtimate C18 column(250 mm×4.6 mm,5μm)with a mobile phase consisting of 0.2 mol·L^(-1) trifluoroacetic acid solution-ethanol(96∶4)at a column temperature of 40℃and the flow rate of 0.7 mL·min^(-1).The evaporative light scattering detector with the drift tube temperature was set at 50℃and the carrier gas pressure was 350 kPa.RESULTS Gentamycin sulfate C1 showed a good linear relationship between 0.1725 and 0.8503 mg·mL^(-1),while C1a between 0.1649 and 0.8129 mg·mL^(-1),C2 between 0.1834 and 0.9038 mg·mL^(-1),and C2a between 0.1118 and 0.5508 mg·mL^(-1)(r≥0.9998),and the average recovery was 99.80%-100.18%with the RSD of 0.36%-1.03%.CONCLUSION The method is environmentally friendly and accurate,and has good compatibility between ethanol and evaporative light scattering detector,and can replace the current HPLC method for the component C in Gentamycin sulfate.

关 键 词：乙醇 高效液相色谱法 硫酸庆大霉素 C组分 绿色分析 职业健康 

分 类 号：R917[医药卫生—药物分析学]