毛细管电泳-非接触电导检测法测定药剂中的硫酸沙丁胺醇

Determination of salbutamol sulfate in medicaments by capillary electrophoresis with contactless conductivity detection

建立了毛细管电泳-非接触电导检测分离测定硫酸沙丁胺醇的分析方法。分别考察了分离介质、背景电解质及其浓度和pH、分离电压、进样时间、激发电压、激发频率等因素对实验结果的影响。在优化的实验条件(以15mmol/L乳酸水溶液(pH 2.7)为电泳介质,10 kV下电动进样3 s,分离电压为10 kV,激发电压为60 V,激发频率为120 kHz)下,硫酸沙丁胺醇的检出限(信噪比为3)为1.92 mg/L,在9.60～48.0 mg/L质量浓度范围内有良好的线性关系(r=0.995),迁移时间的相对标准偏差(RSD)为2.7%。将该方法用于硫酸沙丁胺醇片和硫酸沙丁胺醇气雾剂中的硫酸沙丁胺醇含量的测定,加标回收率为90%～113%,检测结果与药厂的标示值相符合,为硫酸沙丁胺醇的检测提供了一种简便、快速、高灵敏的方法。

A method for the determination of salbutamol sulfate in medicaments by capillary electrophoresis with contactless conductivity detection has been developed. The effects of several important factors, such as nonaqueous and aqueous solvents, background electrolyte and its concentration as well as the pH, separation voltage, sample injection time, excitation voltage and excitation frequency, were investigated. The optimized separation conditions were as follows ： the running buffer was an aqueous solution （pH 2.7） containing 15 mmol/L lactic acid, the separation voltage was 10 kV, the electrokinetic injection time was 3 s at 10 kV, the excitation voltage was 60 V, and the excitation frequency was 120 kHz. The results have shown that there was a linear relationship （ r = 0. 995 ） between the response of the peak area and the mass concentration of salbutamol sulfate in the range from 9.60 to 48.0 mg/L, and the limits of detection （S/N = 3 ） was 1.92 mg/L. The relative standard deviation for the migration time of salbutamol sulfate was 2.7%. The method has been successfully applied in the determination of the contents in the tablet and aerosol of salbutamol sulfate, separately. The results were in accordance with the values marked by the pharmaceutical industry. Moreover, the recoveries were 90% - 113%. This simple and quick analytical method can be used for determining salbutamol sulfate.