HPLC-ELSD法测定硫普罗宁注射液中依地酸钙二钠的含量___

 

目的：建立测定硫普罗宁注射液中依地酸钙二钠含量的高效液相色谱-蒸发光散射（HPLC-ELSD）测定方法。方法：采用Waters Symmetry C₁₈ 柱（250 mm×4.6 mm，5 μm）；以甲醇-0.3%醋酸溶液（20∶80）为流动相；流速：0.8 mL·min^-1；柱温：30 ℃；蒸发光散射检测器：漂移管温度：45 ℃，载气流速：2.4 L·min^-1；进样体积：20 μL。结果：依地酸钙钠浓度在0.25~4 mg·mL^-1范围内呈良好的对数线性关系，r=0.9997；硫普罗宁注射液的平均加样回收率(n=9)为100.4%。结论：该方法快速、简便，结果准确可靠，重复性好，适用于测定硫普罗宁注射液中依地酸钙二钠含量。

 

 

Objective:To establish a novel method for the quantitative analysis of calcium disodium edentate in tiopronin injection by HPLC-ELSD.Method:The chromatographic analysis were carried out on a Waters Symmetry C₁₈ column(250 mm×4.6 mm，5 μm)，and the mobile phase consisted of methanol and 0.3% acetic acid(20∶80).Flow rate was 0.8 mL·min-1,and the column temperature was 30 ℃.The flow rate N2 in ELSD was 2.4 L·min-1；The temperature of drift tube was 45 ℃.Results:Calcium disodium edetate curves were linear in the range of 0.25-4 mg·mL-1.The average recovery(n=9) of tiopronin injection was 100.4%.Conclusion:The method is simple and rapid,the results are accurate and reproducible,which is suitable for the determination of calcium disodium edentate in tiopronin injection.

1LUO Ming-sheng（罗明生），GAO Tian-hui（高天惠）.The Extra Pharmaceutical Necessities（药剂辅料大全）.Chengdu（成都）：Sichuan Science and Technology Publishers（四川科学技术出版社），1993.55

2Raymond C Rowe，Paul J Sheskey,Paul J Weller.Handbook of Pharmaceutical Excipients.Pharmaceutical Press and American Pharmaceutical Association,2003.261

3ChP（中国药典）2005.Vol II（二部）：341

4ZHANG Bo（张波），XU Guo-cun（徐国存）.Caicium disodium edetate according to 14 cases of neutropenia analysis(依地酸钙钠致粒细胞减少14例分析).Ind Health Occup Diseases（工业卫生与职业病），1998，18（9）：550

5WANG Li-hong（王立红），HOU Xiao-yan（侯晓艳）.Caicium disodium edetate according to a case of anaphylactic shock(依地酸钙钠致过敏性休克一例). Ind Health Occup Diseases（工业卫生与职业病），2002，28（4）：240