HPLC法测定复方塞啦嗪注射液中盐酸二氢埃托啡的含量

HPLC determination of dihydroetorphine hydrochloride in compound xylazine injection

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 determine the content of dihydroetorphine hydrochloride in compound xylazine injection by HPLC. Methods： The C18 （ 250 mm × 4. 6 mm,5 μm） column was used ; the mobile phase was methanol - acetonitrile-0. 02 mol · L^-1potassium dihydrogen phosphate（20： 7： 73） ,pH was adjusted to 3.8 -4. 0 by H3PO4 ;the flow rate was 1.0 mL · min^-1 ,the wavelength used for detection was 286 nm. Results：The linear range of dihydroetorphine hydrochloride was 10 - 30 μg · mL^-1 （ r = 0. 9995 ） ; the average recoveries （ n = 3 ） of dihydroetorphine hydrochloride were 98.8% ,99.8% and 99.3% ,and their RSDs were 0.64% ,0. 87% and 0. 48% ,respectively; RSD of between - day and within - day were 0. 64% - 0.89% and 0.60% - 0. 92%, separately. Conclusion： A convenient, rapid, and effective method has been provided for determining the content of dihydroetorphine hydrochloride in compound xylazine injection.