摘要
目的:建立高效液相色谱法测定醋酸可的松有关物质及其注射液含量的方法。方法:采用DiamonsilTMC18色谱柱(250mm×4.6mm,5μm);以乙腈-水(36∶64)为流动相,检测波长为254nm,柱温35℃,流速为1mL·min-1。结果:醋酸可的松的线性范围分别为0.53～31.95μg·mL-1(有关物质,杂质限度在0.05%～3.0%)和10.23～306.9μg·mL-1(含量测定);其线性回归方程分别为Y=2.078×103X+1.283×102,r=0.9999(n=8)和Y=2.067×103X-1.251×102,r=0.9999(n=7)。醋酸可的松注射液含量测定的平均回收率为101.0%,RSD为0.36%(n=9)。结论:本方法操作简便、快速,精密度好,结果准确可靠。
Objective：An HPLC method was established for the determination of related substances in cortisone acetate and assay of cortisone acetate injection. Methods： The separation was performed on an Diamonsil^TMC18 column （250mm×4. 6mm, 5μm）. The mobile phase was composed of acetonitrile-water（36 ： 64） with flow rate 1mL · min^-1 ,detected at 254nm. The column temperature was 35℃. Results ：The calibration curve were linear in the range of 0. 53～ 31.95μg · mL^-1 （in related substances ） and 10. 23 ～ 306.9μg · mL^-1 （in contents）, respectively. The average recovery was 101.0 % （n= 9）. Conclusion： The method is simple,rapid,accurate and reliable.
出处
《中国药品标准》
CAS
2006年第3期38-41,共4页
Drug Standards of China
