Application of an HPLC correction factor method in pharmaceutical analysis
10.16438/j.0513-4870.2020-0697
- VernacularTitle:HPLC校正因子法在药物分析中的应用
- Author:
Ting XIAO
;
Chen WANG
;
Shang-chen YAO
;
Yan-chun FENG
;
Chang-qin HU
- Publication Type:Research Article
- Keywords:
HPLC;
correction factor;
response factor;
main component self-contrast method;
substitute reference substance method
- From:
Acta Pharmaceutica Sinica
2020;55(12):2854-2861
- CountryChina
- Language:Chinese
-
Abstract:
With the in-depth study of related substances and the development of consistency evaluation of generic drugs, relative correction factors are gaining increasing attention. By analyzing the domestic and foreign literature on correction factors in recent years, this paper describes the correction factor component, the current measurement method and its application. The rules and key points of use of an impurity correction factor and its determination and application are described, and some problems in its determination and application are discussed, providing a reference and basis for the standardization of research on impurity correction factors in the future.
