高效液相色谱法测定酪丝缬肽及其制剂的含量及有关物质  

HPLC determination of the content and the related substances of tyroservatide and its preparation

作　　者：李勇 廖海明[2] 胡亚兵 杨化新[2] 

机构地区：[1]深圳市康哲药业有限公司,深圳518029 [2]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2007年第1期93-95,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高效液相色谱法测定酪丝缬肽及其制剂注射用酪丝缬肽的含量及有关物质。方法:采用反相高效液相色谱法,固定相为十八烷基硅烷键合硅胶,流动相为0.1 mol·L^(-1)磷酸二氢钠溶液-乙腈系统,梯度洗脱,流速1.0 mL·min^(-1),检测波长220 nm。结果:进样量在9.972～4986 ng 范围内,与峰面积呈良好的线性关系(r=1.000),最低检测限为0.8 ng。制剂平均回收率(n=3)分别为100.0%,99.9%,100.1%;RSD 分别为0.26%,0.06%,0.31%。结论:方法专属性好,准确、灵敏,用于酪丝缬肽及制剂的含量及有关物质测定结果可靠。Objective： To establish an RP - HPLC method to determine the content and the related substances of tyroservatide and its preparation. Method：Use a C lscolumn and 0. 1mol·L^-1 sodium dihydrogen phosphate solution - acetonitrile as the mobile phase at the flow rate of 1.0 mL · min^-1. The detection wavelength was 220 nm. Resuits：The linear range was 9. 972 -4986 ng（r = 1. 000） ;the limit of the detection was 0. 8 ng;the average recoveries of the preparation were 100. 0% （RSD =0. 26% ） ,99.9% （RSD =0. 06% ） ,100. 1% （RSD =0. 31% ）. Conclusion： The method is simple, accurate, sensitive and reliable for determination of tyroservatide and its preparation.

关 键 词：酪丝缬肽 注射用酪丝缬肽 高效液相色谱法 含量 有关物质 

分 类 号：R917[医药卫生—药物分析学]