药学学报  2020, Vol. 55 Issue (12): 2854-2861     DOI: 10.16438/j.0513-4870.2020-0697 PDF
HPLC校正因子法在药物分析中的应用

Application of an HPLC correction factor method in pharmaceutical analysis
XIAO Ting, WANG Chen, YAO Shang-chen, FENG Yan-chun, HU Chang-qin
National Institutes for Food and Drug Control, Beijing 102629, China
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.
Key words: HPLC    correction factor    response factor    main component self-contrast method    substitute reference substance method

1 定义

 $f=\frac{c_{待测物}⁄A_{待测物} }{c_{参比物}⁄A_{参比物} }$ (1)

2 测定方法 2.1 HPLC-UV/PDA方法 2.1.1 单点法

2.1.2 多点法

2.1.3 标准曲线法

 $f = {k_{参比物}}/{k_{待测物}}$ (2)

2.1.4 联立方程法

2.2 紫外吸光系数比值法

 $f = {E_{参比物}}/{E_{待测物}}$ (3)

2.3 HPLC联用其他方法 2.3.1 HPLC-UV/PDA串联其他检测器方法

 $f=\frac{A_\rm{待测物UV峰面积}/A_{待测物质量型检测器峰面积}}{A_\rm{参比物UV峰面积}/A_{参比物质量型检测器峰面积} }$ (4)

2.3.2 HPLC-UV/PDA检测器结合核磁定量方法

 ${\rm{RR}}{{\rm{F}}^{{\rm{UV}}}} = \frac{{A_{待测物}^{{\rm{UV}}}}}{{A_{参比物}^{{\rm{UV}}}}} \times \frac{{I_{参比物}^{{\rm{NMB}}}}}{{I_{待测物}^{{\rm{NMB}}}}} \times \frac{{{M_{\rm{r参比物}}}}}{{{M_{\rm{r待测物}}}}} \times \frac{{N_{待测物}^{\rm{H}}}}{{N_{参比物}^{\rm{H}}}}$ (5)

3 应用 3.1 在有关物质含量测定中的应用

3.2 在中药及其复方制剂多指标成分测定中的应用

4 问题和小结 4.1 标准曲线法校正因子的测定

4.1.1 曲线是否需要强制过原点

4.1.2 校正曲线浓度范围的选择

4.1.3 校正曲线上浓度点的选择

4.1.4 涉及校正因子的方法开发与验证

4.2 校正因子的使用

5 展望