摘要
目的:建立注射用去甲斑蝥酸钠含量及有关物质测定方法。方法:采用C18柱(4.6×250mm,5μm)与紫外检测器,0.02mol·L-1磷酸二氢钾溶液(用磷酸调节pH值至3.0)-甲醇(75:25),流速1.0ml·min-1,测定波长211nm。结果:注射用去甲斑蝥酸钠在6.0μg～16.0μg范围内线性关系良好,r=0.9995。平均回收率为99.6%,RSD=0.16%,定量限为0.4μg。结论:本方法专属性强,准确度高、重现性好。
Objective：To develop a method for determination of content and related substances in Norcantharidin for Injection. Metbods： The C18（4.6 × 250mm, 5 um）column was used. The mobile phase was 0. 02 mol/L monobasic Potassium Phosphate （adjust the pH to 3. 0 with phosphoric acid）-methanol （75 ： 25）with flow rate of 1.0 ml ·min^-1. The detective wavelength was at 211nm. Results：The linear relationship of norcantharidin was within the range of 6.0ug -16.0ug（r= 0. 9995）. The average recovery was 99.5 % ,RSD was 0. 16 % ,detectable limit was 0. 4ug. Conclusion ： The method is reliable,accurate and reproducibe.
出处
《中国药品标准》
CAS
2007年第2期56-58,共3页
Drug Standards of China
