Establishing the chromatographic fingerprint of traditional Chinese medicine standard decoction based on quality by design approach: A case study of Licorice
Establishing the chromatographic fingerprint of traditional Chinese medicine standard decoction based on quality by design approach: A case study of Licorice
复制标题
基于质量设计方法的中药标准汤剂色谱指纹图谱建立——以甘草为例
DOI：
10.1002/jssc.201800989
复制
发表时间：
2019-03-01
影响因子：
3.1
通讯作者：
Yan, Jizhong
中科院分区：
文献类型：
--
作者：
Zhang, Hui;Wang, Jianan;Yan, Jizhong
以甘草标准汤剂为例，建立了一种新的基于质量设计的中药指纹图谱分析方法。考虑到完整性和模糊性的特点，选择8个常见峰的分离度、总峰数、容量因子分布和峰纯度作为评价色谱指纹图谱质量的潜在关键方法属性。采用中心复合设计评价关键方法属性与关键方法参数（包括柱温、波长、流速、甲酸浓度和梯度参数）之间的关系。采用标准概率法计算指纹图谱分析参数的设计空间，评价方法学的稳健性。优化的高效液相色谱指纹图谱条件为乙腈和0.1%甲酸水梯度洗脱（0-5分钟，5- 19%A; 5-10分钟，19%A; 10-50分钟，19- 42%A; 50-54分钟，42- 100%A; 54-60分钟，100%A），柱温25 +/-5 ° C，检测波长265 nm。基于设计分析质量的指纹图谱分析方法设计空间不仅满足指纹图谱分析的要求，而且提高了指纹图谱分析方法的稳健性和适用性。
A novel analytical quality by design approach for developing a chromatographic fingerprint was established for analyzing complex traditional Chinese medicine, using a licorice standard decoction as an example. Considering the characteristics of integrity and ambiguity, the resolution of eight common peaks, total peak number, capacity factor distributions, and peak purity were selected as potential critical method attributes for assessing the quality of the chromatographic fingerprint. A central composite design was used to evaluate the relationship between critical method attributes and critical method parameters, including column temperature, wavelength, flow rate, formic-acid concentration, and gradient parameters. A standard probability method was employed to calculate the design space of the fingerprint analysis parameters and evaluate the robustness of the methodology. The optimized high-performance liquid chromatography fingerprint conditions were acetonitrile and 0.1% formic acid water gradient elution (0-5 min, 5-19% A; 5-10 min, 19% A; 10-50 min, 19-42% A; 50-54 min, 42-100% A; 54-60 min, 100% A), column temperature 25 +/- 5 degrees C, detection wavelength 265 nm. The design space of fingerprint analytical method based on the analytical quality by design approach not only met the requirements of the fingerprint analysis, but also improved the robustness and applicability of the fingerprint method.