HILIC-ELSD法测定盐酸多巴酚丁胺注射液中亚硫酸氢钠和依地酸二钠的含量

目的：建立亲水作用色谱-蒸发光散射检测器联用测定盐酸多巴酚丁胺注射液中亚硫酸氢钠和依地酸二钠含量的方法。方法：采用ZIC—HILIC柱（4．6mm×150mm，5μm）；100mmol·L^-1乙酸胺溶液（pH6．0）为流动相A，乙腈为流动相B，梯度洗脱；蒸发光散射检测器：漂移管温度45℃，气体压力40psi；流量0．5mL·min^-1。结果：亚硫酸氢钠在0．8—6．2mg·mL^-1范围内呈良好的线性关系，平均回收率99．1％，RSD为0．6％；依地酸二钠在0．08～0．50mg·mL^-1浓度范围内线性良好，平均回收率99．5％，RSD为0．4％。结论：所建方法简便、灵敏度高，重现性好，可用于盐酸多巴酚丁胺注射液中亚硫酸氢钠和依地酸二钠的含量测定。

HILIC-ELSD Determination of Sodium Bisulfite and Disodium Edetate in Dobutamine Hydrochloride Injection

Abstrac Objective： To estabilish an HILIC-ELSD method for determination of sodium bisulfate and disodium edetate in dobutamine hydrochloride injection. Method： The separation was performed on ZIC-HILIC column（4. 6 mm× 150 mm,5 μm） with 100 mmol·L^-1 ammonium acetate as mobile A, acetonitrile as mobile B, gradient elution, at a flow rate of 0. 5 mL·min^-1 . An evaporative light- scattering detector（ESLD）was used with gas pressure of 40 psi and drift tube temperature of 45 %. Results： There was a good liner relationship of sodium bisulfate in the range of 0. 8-6. 2 mg · mL^-1 ,the average recovery was 99. 1% （ RSD =0. 6% ） . There was a good liner relationship of disodium edetate in the range of 0.08-0. 50 mg · mL^-1 ,the average recovery was 99. 5% （ RSD =0. 4% ）. Conclusion： The method is simple, sensitive and reliable, it can be used as quantitative analysis method for sodium bisulfite and disedium edta in dobutamine hydrochloride injection. Key words： HILIC; dobutamine hydrochloride injection; sodium bisulfate; disodium edetate