目的:建立多指标含量测定结合化学计量学分析,评价消乳散结胶囊质量。方法:采用Hypersil GOLDC18色谱柱(250 mm× 4.6 mm,5 μm),乙腈(A)-0.2% 磷酸水溶液(B)为流动相,梯度洗脱,流速1 mL·min-1,检测波长230 nm,柱温25 ℃,进样量10 μL。结果:消乳散结胶囊中芍药苷、迷迭香酸、黄芩苷、丹酚酸B、汉黄芩苷、丹皮酚的色谱峰均能达到基线分离,线性关系良好,平均回收率分别为100.0%、97.8%、99.7%、97.6%、97.4%、100.3%,RSD 均≤2.0%。该方法的精密度、稳定性、重复性良好。13批消乳散结胶囊中上述6 个成分的含量测定结果分别为2.592~4.509、0.582~0.978、2.343~3.743、2.373~4.743、0.522~1.049、2.949~3.928 mg·g-1。化学计量学分析表明不同批次产品存在一定差异,区分各类样品的强特征峰为芍药苷、丹酚酸B 和黄芩苷。结论:建立的综合质量评价法准确、专属,可用于消乳散结胶囊的质量控制。
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