摘要
目的建立首批酪丝亮肽国家对照品。方法应用紫外分光光度计、液质联用仪等对酪丝亮肽进行结构确证,采用反相高效液相色谱法测定纯度及氨基酸比值,采用3种方法进行含量测定。结果确证了酪丝亮肽原料的结构,并确定首批酪丝亮肽对照品含量为96.8%。结论首批酪丝亮肽国家对照品(批号:140742-200701)的建立可有效控制产品质量。
Objective To establish the national reference substance for tyroserleutide. Methods UV spectrometer and LC-MS were used to confirm the structure of the material. RP-HPLC were used to determine the purity and the ratio of amino acid of tyroserleutide, and 3 methods were used to determine the content of the material. Results The structure of the material was confirmed, and the content of tyroserleutide was 96.8%. Conclusion The establishment of national reference substance （lot No： 140742- 200701） for tyroserleutide can efficiently control the quality of products.
出处
《中国药事》
CAS
2013年第10期1077-1079,共3页
Chinese Pharmaceutical Affairs
基金
创新药物研究开发技术平台建设(编号2012ZX09304010)
关键词
酪丝亮肽
国家对照品
标准和标定
质谱
反相高效液相色谱法
tyroserleutide
national reference substance
standardization of stardard sabstance
MS
RP-HPLC
