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目的建立测定田参氨基酸胶囊中药类成分含量的高效液相色谱(HPLC)法,以全面有效控制田参氨基酸胶囊质量。方法采用Phenomenex Kinetex C_(18)色谱柱(100 mm×4.6 mm,2.6μm);流动相:乙腈-水,梯度洗脱,流速:0.8 mL·min~(-1);检测波长:203 nm;柱温:30℃。结果三七皂苷R_1、人参皂苷Rg_1、Re、Rb_1、Rd线性范围分别为0.060 9~0.811 6,0.237 2~3.162 8,0.237 2~3.162 8,0.038 7~0.526 0,0.226 9~3.012 0,0.226 9~3.012 0和0.058 1~0.774 8 mg·mL~(-1)(r≥0.999 8);阴性无干扰;精密度、稳定性、重复性良好;回收率在93%~103%范围内。结论建立的方法准确、简便、重复性好,可用于田参氨基酸胶囊的质量控制。
OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for the determination of the content of Chinese herbs in amino acid capsules of Vitex negundo, in order to fully and effectively control the quality of the amino acid capsules of field. Methods The mobile phase consisted of acetonitrile - water with gradient elution at a flow rate of 0.8 mL · min -1 on a Phenomenex Kinetex C 18 column (100 mm × 4.6 mm, 2.6 μm). The detection wavelength was 203 nm. Column temperature: 30 ℃. Results The linear ranges of notoginsenoside R_1, ginsenoside Rg_1, Re, Rb_1, Rd were 0.060 9 ~ 0.811 6,0.237 2 ~ 3.162 8,0.237 2 ~ 3.162 8,0.038 7 ~ 0.526 0,0.226 9 ~ 3.012 0,0.226 9 ~ 3.012 0 and 0.058 1 ~ 0.774 8 mg · mL -1 (r≥0.999 8). The results showed no interference with negative results. The precision, stability and repeatability were good. The recoveries ranged from 93% to 103%. Conclusion The established method is accurate, simple and reproducible. It can be used for the quality control of amino acid capsule.