Methods. The influences of methanol proportion, flow rate, column temperature, and injection volume in the mobile phase on the chromatographic resolution of chromatographic peak of euphorbia factor L1 were experimentally studied via Plackett–Burman design, and the key analysis parameters were screened out; the key analysis parameters were optimized through the central composite design, and the chromatographic analysis conditions were established. Euphorbia factor L1 was taken as the internal reference to construct the relative correction factors for L3 and L4 relative to L1, and their contents were calculated, thus realizing the QAMS. Meanwhile, the euphorbia factor L3 and euphorbia factor L4 were determined using the external standard method, and the differences of values measured by the external standard method from the values predicted by the QAMS method were compared, in an effort to verify the accuracy and feasibility of the QAMS method. Results. The methanol proportion and column temperature in the mobile phase were the key analysis parameters , and the chromatographic conditions were determined as follows. The methanol/water ratio, column temperature, detection wavelength, flow rate, and injection volume were 60 : 40, 30°C, 275 nm, 1.0 mL/min, and 10 μL, respectively. A total of 20 batches of samples were determined by the QAMS method and external standard method; the relative standard deviations (RSDs) of L3 and L4 determination results were less than 2.0%, without any significant difference. Conclusion. The QbD-based QAMS method can be used to determine the contents of euphorbia factor L3 and euphorbia factor L4 in Euphorbia lathyris L., and it is accurate and feasible.

中文翻译：

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基于质量源于设计理念的山黧豆单标记法建立山黧豆多指标定量分析

方法。采用Plackett-Burman设计实验研究了流动相中甲醇比例、流速、柱温、进样量对大戟因子L1色谱峰色谱分离度的影响，筛选出关键分析参数；通过中心组合设计优化关键分析参数，建立色谱分析条件。以大戟因子L1为内参，构建L3和L4相对于L1的相对校正因子，并计算其含量，从而实现QAMS。同时，采用外标法测定大戟因子L3和大戟因子L4，并比较外标法测定值与QAMS法预测值的差异，验证大戟因子L3和L4的准确性和可行性。 QAMS 方法。结果。流动相中甲醇比例和柱温是关键分析参数，色谱条件确定如下。甲醇/水比、柱温、检测波长、流速、进样量分别为60:40、30℃、275 nm、1.0 mL/min、10  μL。共20批次样品采用QAMS法和外标法进行测定；L3和L4测定结果的相对标准偏差（RSD）均小于2.0%，无显着性差异。结论。基于QbD的QAMS方法可用于测定山黧豆中大戟因子L3和大戟因子L4的含量，且准确可行。