复方益母口服液中水溶性生物碱-盐酸水苏碱的HPLC法测定研究

Determination of water soluble alkaloids-stachydrine hydrochloride in Complex Yimu Oral Liquid by HPLC

目的建立复方益母口服液中水溶性生物碱-盐酸水苏碱的含量测定方法。方法用雷氏盐沉淀法处理样品,对提纯出的盐酸水苏碱采用HPLC法测定含量。色谱柱为Agela Venusil XBP NH2柱(4.6mm×250mm,5μm),以乙腈-醋酸溶液(用少量醋酸调节溶液的pH值至3.00±0.15)(77:23)为流动相,流速为1.0mL/min,柱温为35℃,检测波长200nm。结果复方益母口服液中盐酸水苏碱的进样量在1.0831～32.4918μg范围内线性关系良好(r=0.9999),平均回收率为91.1%,RSD=3.7%(n=6)。结论该方法精确可靠,专属性强,可作为复方益母口服液中盐酸水苏碱的质量控制方法。

Objective To establish a method for the content determination of water soluble alkaloids-stachydrine hydrochloride in Complex Yimu Oral Liquid.Methods The sample solution was prepared with the method of Reinecke salt precipitation and was determined the content by HPLC.The column was Agela Venusil XBP NH2 column（4.6 mm×250 mm,5 μm） and CH3CN-H2O（pH was adjusted to 3.00±0.15 by acetic acid）（77：23） was used as the mobile phase,with the flow rate of 1.0 mL/min.The column temperature was at 35℃ and the detection wavelength was 200 nm.Results The good linear ranges were between 1.083 1-32.491 8 μg for stachydrine hydrochloride（r = 0.999 9,n = 6） and the average rate of recovery was 91.1% with RSD = 3.7%（n = 6）.Conclusion The method is accurate,reliable,specific and with good reproducibility.It can be used for the quality control of stachydrine hydrochloride in Complex Yimu Oral Liquid.