Quantification and discovery of quality control chemical markers for Shouhui Tongbian capsules by UPLC-MS/MS

IF 2.6 3区化学 Q2 CHEMISTRY, ANALYTICAL

Analytical Methods Pub Date : 2025-08-20 DOI:10.1039/D5AY00842E

Jieting Zhang, Shuo Diao, Zhen Huang, Mengyuan Wu, Xintong Wang, Yiran Zhao, Mingming Yu, Xianzhen Wang, Jingchun Yao, Guimin Zhang, Sherwin K. B. Sy, Zhihua Lv and Hai Yang

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Abstract

Guided by the principles of Analytical Quality by Design (AQbD), a highly selective and sensitive LC-MS/MS method was established for the simultaneous quantification of 15 compounds in Shouhui Tongbian capsules, enabling their effective quality control. The separation was carried out on a BEH C18 column (1.7 μm, 2.1 × 100 mm) with a mobile phase comprising 0.1% formic acid in 3 mM ammonium acetate aqueous solution and methanol (60 : 40, v/v) at a flow rate of 0.30 mL min⁻¹. The method exhibited good linearity within a certain concentration range (R² > 0.9906) depending on the compound; the precision ranged from 0.6% to 14.7% and accuracy was within 11.2%. Among the 15 detected compounds, aloin had the highest content in the Shouhui Tongbian capsules, reaching 227.3780 mg g⁻¹, followed by betaine and L-hydroxyproline, with concentrations of 1.3204 mg g⁻¹ and 1.2929 mg g⁻¹, respectively. This method simultaneously detected the content of 15 compounds in five batches of Shouhui Tongbian capsules.

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高效液相色谱-质谱联用技术测定寿会通边胶囊的质量控制化学标记

以定量设计（AQbD）原则为指导，建立了高选择性、高灵敏度的LC-MS/MS同时定量寿会通便胶囊中15种化合物的方法，实现了寿会通便胶囊的有效质量控制。色谱柱为BEH C18 (1.7 μm, 2.1 × 100 mm)，流动相为0.1%甲酸- 3 mm醋酸铵水溶液-甲醇（60:40,v/v），流速为0.30 mL min - 1。该方法在一定浓度范围内呈良好的线性关系（R2 > 0.9906）；精密度为0.6% ~ 14.7%，准确度在11.2%以内。15种化合物中，首会通边胶囊中芦荟素含量最高，达227.3780 mg g−1，其次为甜菜碱和l -羟脯氨酸，分别为1.3204 mg g−1和1.2929 mg g−1。本方法同时测定了5批寿会通便胶囊中15种化合物的含量。

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