This study uses a liquid chromatography-electrospray ionization-tandem mass spectrometry method to determine β-Sitosterol and Ferulic acid in Pygeum africanum extract. Chromatographic separation of the two analytes was performed on an ACQUITY UPLC H-Class system coupled with Xevo TQD mass spectrometer and HSS T3 C18 column (2.1 X 50 mm, 1.8 μm). Mobile phase A consisted of an aqueous solution of 0.1% formic acid (v/v), and mobile phase B was 0.1% formic acid (v/v) in methanol pumped through a gradient elution mode. Mass spectrometer parameters were optimized using an electrospray ionization source in the positive and negative ionization modes. The quantification of the two analytes was performed using multiple reaction monitoring transitions. The method was fully validated per (FDA) guidelines regarding linearity, accuracy, precision, carryover and selectivity. The proposed method was applied successfully to determine the two investigated compounds in commercially available pharmaceutical products.

中文翻译：

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定量散装和药物制剂中非洲臀果木提取物中 β-谷甾醇和阿魏酸的 UPLC-MS/MS 方法。

本研究采用液相色谱-电喷雾电离-串联质谱法测定非洲臀果木提取物中的β-谷甾醇和阿魏酸。在 ACQUITY UPLC H-Class 系统上结合 Xevo TQD 质谱仪和 HSS T3 C18 色谱柱（2.1 X 50 mm，1.8 μm）对两种分析物进行色谱分离。流动相 A 由 0.1% 甲酸 (v/v) 水溶液组成，流动相 B 为 0.1% 甲酸 (v/v) 的甲醇溶液，通过梯度洗脱模式泵送。使用电喷雾电离源在正电离和负电离模式下优化质谱仪参数。使用多反应监测转变对两种分析物进行定量。该方法根据 (FDA) 指南对线性、准确度、精密度、残留和选择性进行了全面验证。所提出的方法已成功应用于测定市售药品中的两种研究化合物。