HPLC法测定清开灵注射液中辅料含量  

HPLC Determination of excipients in Qingkailing Injection

作　　者：张悦 曹云飞 张岩岩 Zhang yue;Cao yunfei;Zhang Yanyan(Inspection and Testing Center of Market Regulation Administration of Pinggu District,Beijing 101200,China;Zhenjiang Food and Drug Supervision and Inspection Center;Shineway Pharmaceutical Group Co.,Ltd.,Shijiazhuang 051430,China;Yunnan Provincial Key Laboratory of Formula Granules Chuxiong 675000,China)

机构地区：[1]北京市平谷区市场监督管理局检验检测中心,北京101200 [2]镇江市食品药品监督检验中心 [3]神威药业集团有限公司,石家庄051430 [4]云南省配方颗粒重点实验室,楚雄675000

出　　处：《现代科学仪器》2023年第4期17-22,共6页Modern Scientific Instruments

基　　金：中央引导地方科技发展资金项目,项目名称:经典名方开发关键技术体系创建及应用(项目编号:206Z2502G)。

摘　　要：目的:建立清开灵注射液中辅料硫代硫酸钠和依地酸二钠的含量测定方法。方法:使用高效液相色谱法检测硫代硫酸钠和依地酸二钠的含量,对于硫代硫酸钠:Inerstil-ODS-SP(250mm×4.6 mm,5μm)色谱柱,乙腈-0.85 g/L的四丁基硫酸氢铵水溶液梯度洗脱;检测波长214 nm,柱温为25℃,流速1mL·min^(-1);对于依地酸二钠,Inerstil-ODS-SP(250mm×4.6mm,5μm)色谱柱;0.3%四丁基氢氧化铵(磷酸调pH至4.0)-乙腈-水(18:37:45)为流动相,流速0.6mL·min^(-1),柱温为25℃,检测波长254nm。结果:硫代硫酸钠、依地酸二钠分别在10.12~303.6μg/mL(R^(2)=0.9999)1.663~49.89μg/mL(R^(2)=0.9999)浓度范围内线性关系良好,平均回收率分别为99.3%和99.6%。结论:该方法可作为清开灵注射液中硫代硫酸钠和依地酸二钠的含量测定方法。Objective:To establish determination methods of contents of sodium thiosulphate and edetate disodium in Qingkailing injection.Method:HPLC was used to determine the contents of sodium thiosulphate and edetate disodium.For sodium thiosulphate,the separation was performed on the Inerstil-ODS-SP column(4.6 mm×250 mm,5μm)at 25℃.The mobile phase consisted of acetonitrile and water with XXX%tetrabutylammonium hydrogen sulfate at a flow rate of 1.0 mL·min^(-1).The detection wavelength was 214 nm.The content determination of edetate disodium was also conducted using Inerstil-ODS-SP column(4.6mm×250mm,5μm).0.3%tetrabutylammonium hydrogen sulfate(whose pH was adjusted to 4.0 by phosphoric acid),acetonitrile and water,with the proportion being 18:37:45,was used as the mobile phase.The flow rate was set at 0.6 mL·min^(-1).The temperature of the column was maintained at 25℃and the signal was detected at 254 nm.Results:A linear relationships between the concentration of test solution and aera could be acquired in 10.12~303.6μg/mL(R^(2)=0.9999)for sodium thiosulphate.The linearity range for edetate disodium was 1.663~49.89μg/mL(R^(2)=0.9999).Average recovery rates were 99.3%and 99.6%,respectively.Conclusion:The method can be used for quality control of Sodium Thiosulfat andedetate disodium in Qingkailing Injection.

关 键 词：清开灵注射液 硫代硫酸钠 依地酸二钠 高效液相色谱法 

分 类 号：TH7[机械工程—仪器科学与技术]