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目的:建立复方塞啦嗪注射液中盐酸二氢埃托啡的含量测定方法。方法:以C18(250mm×4.6mm,5μm)色谱柱为分析柱,甲醇-乙腈-0.02mol.L-1磷酸二氢钾水溶液(20:7:73,以磷酸调pH3.8～4.0)为流动相;流速1.0mL.min-1;于检测波长286nm下进行检测,进样量20μL。结果:盐酸二氢埃托啡浓度在10～30μg.mL-1范围内,与峰面积呈良好的线性关系(r=0.9995);其定量限为20ng。低、中、高3种浓度平均回收率(n=3)为98.8%,99.8%,99.3%;RSD分别为0.64%,0.87%,0.48%。日内、日间RSD(n=3)分别为0.64%～0.89%和0.60%～0.92%。结论:本法用于测定复方塞啦嗪注射液中盐酸二氢埃托啡的含量,方法简便、专属性较高、结果准确可靠。
Objective: To establish a method for the determination of dihydroetorphine hydrochloride in compound selazine injection. METHODS: The analytical column was C18 (250mm × 4.6mm, 5μm) column. The methanol-acetonitrile-0.02mol.L-1 aqueous potassium dihydrogen phosphate solution (20: 7: 73, adjusted to pH3.8-4.0 with phosphoric acid) Mobile phase; flow rate 1.0mL.min-1; detection wavelength 286nm for testing, injection volume 20μL. Results: The concentration of dihydroetorphine hydrochloride in the range of 10 ~ 30μg.mL-1 showed a good linear relationship with the peak area (r = 0.9995). The limit of quantitation was 20ng. The average recoveries (n = 3) of three kinds of low, medium and high concentrations were 98.8%, 99.8% and 99.3%, respectively. The RSDs were 0.64%, 0.87% and 0.48%, respectively. Day and day RSD (n = 3) were 0.64% ~ 0.89% and 0.60% ~ 0.92% respectively. Conclusion: This method is used to determine the content of dihydroetorphine hydrochloride in compound selazine injection. The method is simple and convenient, with high specificity and accurate and reliable results.