反相高效液相色谱法测定醋酸氢化可的松注射液的有关物质及眼膏剂的含量

RP-HPLC determination of hydrocortisone acetate eye ointment and its related substances of hydrocortisone acetate injection

目的:建立了HPLC法测定醋酸氢化可的松眼膏的含量及醋酸氢化可的松注射液有关物质的分析方法。方法:采用Agilent HC C18柱(4.6mm×250mm,5μm)色谱柱,以乙腈-水(36∶64)为流动相,检测波长254nm,流速1.0mL.min-1,柱温40℃。结果:醋酸氢化可的松在0.506～202.4μg·mL-1浓度范围内呈良好线性关系,线性方程为A=40.3C+2.68(r=0.99999);醋酸氢化可的松的检测限为10.1ng,定量限为30.1ng;醋酸氢化可的松眼膏的平均回收率为100.4%,RSD=0.29%(n=9)。结论:该方法快速、简便、准确、灵敏、重复性好,并能有效地控制药品质量。

Objective：To develop an RP-HPLC method for determination assay of hydrocortisone acetate eye ointment and its related substances of hydrocortisone acetate injection.Methods：An Agilent HC C18 （4.6 mm×250 mm,5 μm）column was adopted with a mobile phase consisted of a mixture of acethane-water （36：64）at a flow rate of 1.0 mL·min-1 and UV detector wavelength was set at 254 nm,column tempreture was 40 ℃.Result：The liner ranges of hydrocortisone acetate was 0.506-202.4 μg·mL-1 （r=0.9999）.The average recovery of hydrocortisone acetate eye ointment was 100.4%（n=9） with RSD% 0.29%.The LOD was 10.1 ng,LOQ was 30.1 ng.Conclusion：This method is rapid,simple,accurate,sensitive,and it can control the quality of hydrocortisone acetate and hydrocortisone acetate preparation better.