摘要555作为一种长效胰岛素类似物，鉴于其安全有效的特点，已在糖尿病治疗中得到了日益广泛的应用。本课题利用高效液相色谱法（HPLC）来对555含量检测方法的专属性、线性和范围、检测限和定量限、精密度、重复性、回收率、稳定性、耐用性以及系统适用性进行验证，从而为研发人员的分析方法验证工作提供一定的参考。实验结果表明本方法的专属性较好，555溶液浓度在0.12～0.52mg/ml之间时，555溶液浓度和主峰面积之间存在着良好的线性关系，线性回归方程Y=20000000x-35615，线性相关系数达到了0.9997，精密度较高，方法的回收率在100.01%～100.28%之间，检测限和定量限分别为1.3ug/ml、4.4ug/ml，稳定性和重复性较好，各项指标均符合2015版中国药典相关指导原则的要求。本研究最终建立了一个简单、精确、灵敏度较高的555定量分析方法，对同类药物的含量检测和方法验证具有借鉴意义，值得推广和使用。69178

该论文有图2幅，表9个，参考文献13篇。

毕业论文关键词：555  方法建立  方法学验证  高效液相色谱法

The Establishment of No.555 Quantify Analysis Method

Abstract 555 as a long acting basic human insulin analogue ,due to its safe and effective characteristics,has been used in diabetes treatment widely ,the subject has verified specificity ,linear and range,detection limit, limit of quantification, precision of injection,repeatability ,recovery of detection,stability ,durability and system applicability for 555 method by using high performance liquid chromatograp (HPLC),then offers a reference for the developers in validation of analytical methods.The results show that the 555 concentration is between 0.12~0.52mg/ml, there is a good linear relationship between the concentration and peak area of 555. Correlation linear equations for Y=20000000x+35615, linear correlation coefficient is 0.9997, precision of injection of the standard deviation (RSD) was 0.09%, recovery rate of method in 100.01%~100.28%, limit of detection and limit of quantification are 1.3ug/ml 4.4ug/ml, stability and repeatability are better, indicators are character 2015 Chinese Pharmacopoeia requirements of chemical drug testing project.This research eventually established a simple, accurate and high sensitivity of the 555 quantitative analysis method, for similar drug testing content and method validation with reference, worthy of promotion and application.

This paper has 2 figures, 9 tables, 13 references.

Key words：555  HPLC  Method Establishment  Method Validation 

目  录

摘要 Ⅰ

Abstract Ⅱ

目录 Ⅲ

图清单 Ⅳ

表清单 Ⅳ

变量注释表 Ⅳ

1 绪论 5

2 材料和方法 6

2.1仪器和试剂 6

2.2溶液配制 7

2.3定量分析方法的建立 7

2.4定量分析方法的评价 8

3 结果与分析 10

3.1专属性评价 10

3.2线性和范围评价 12

3.3检测限和定量限评价 12

3.4精密度评价 13

3.5重复性评价 13

3.6回收率评价