HPLC波长切换法同时测定心神安胶囊中9种成分的含量

Simultaneous Determination of Nine Components in Xinshen'an Capsule by HPLC Wavelength Switching Method

目的建立HPLC波长切换法同时测定心神安胶囊中9种成分的含量。方法采用AgilentEclipseXDB-C18色谱柱,流动相乙腈(A)-0.1%甲酸溶液(B),梯度洗脱;流速0.9 mL·min^(-1);检测波长分别为320 nm[检测远志(口山)酮Ⅲ、3,6’-二芥子酰基蔗糖]、203 nm(检测人参皂苷Rb1、绞股蓝皂苷XLIX、绞股蓝皂苷XVII)和254 nm(检测毛蕊异黄酮葡萄糖苷、芒柄花苷、毛蕊异黄酮、芒柄花素);柱温25℃。结果远志(口山)酮Ⅲ、3,6’-二芥子酰基蔗糖、人参皂苷Rb1、绞股蓝皂苷XLIX、绞股蓝皂苷XVII、毛蕊异黄酮葡萄糖苷、芒柄花苷、毛蕊异黄酮、芒柄花素分别在2.070～41.40μg·mL^(-1)(r=0.999 2)、3.860～77.20μg·mL^(-1)(r=0.999 6)、11.29～225.8μg·mL^(-1)(r=0.999 8)、5.070～101.4μg·mL^(-1) (r=0.999 9)、19.86～397.2μg·mL^(-1)(r=0.9995)、1.280～25.60μg·mL^(-1)(r=0.9991)、0.9600～19.20μg·mL^(-1)(r=0.9993)、0.670 0～13.40μg·mL^(-1)(r=0.999 7)、2.580～51.60μg·mL^(-1)(r=0.999 1)内线性关系良好,平均回收率分别为98.04%,99.26%,99.05%,97.42%,100.0%,98.27%,97.81%,96.84%和99.86%,RSD分别为1.28%,0.82%,1.43%,1.43%,0.86%,1.26%,1.38%,1.16%和0.69%。结论本方法操作简便、准确、重复性好,能够对心神安胶囊中9种成分进行同时含量测定,为提高和完善心神安胶囊的质量标准提供了有效方法。

OBJECTIVE To establish an HPLC wavelength switching method simultaneous determination of nine components in Xinshen’an capsule.METHODS The analysis of this drug was performed on a Agilent Eclipse XDB-C18 column,with the mobile phase of acetonitrile(A)-0.1%formic acid solution(B)flowing at 0.9 mL·min-1 in a gradient elution manner,and the detection wavelength were set at 320 nm(polygalaxanthoneⅢ,3,6’-disinapoyl sucrose),203 nm(ginsenoside Rb1,gypenoside XLIX,gypenoside XVII)and 254 nm(calycosin7-O-β-D-glucopyranoside,ononin,calycosin,formononetin).The column temperature was maintained at 25℃.RESULTS The linear response ranges were 2.070-41.40μg·mL-1(r=0.999 2),3.860-77.20μg·mL-1(r=0.999 6),11.29-225.8μg·mL-1(r=0.999 8),5.070-101.4μg·mL-1(r=0.999 9),19.86-397.2μg·mL-1(r=0.999 5),1.280-25.60μg·m L-1(r=0.999 1),0.960 0-19.20μg·mL-1(r=0.999 3),0.670 0-13.40μg·mL-1(r=0.999 7),2.580-51.60μg·m L-1(r=0.999 1)of polygalaxanthoneⅢ,3,6’-disinapoyl sucrose,ginsenoside Rb1,gypenoside XLIX,gypenoside XVII,calycosin7-O-β-D-glucopyranoside,ononin,calycosin and formononetin.The average recoveries were 98.04%,99.26%,99.05%,97.42%,100.0%,98.27%,97.81%,96.84%and 99.86%.RSD were 1.28%,0.82%,1.43%,1.43%,0.86%,1.26%,1.38%,1.16%and 0.69%,respectively.CONCLUSION The methods with good reproducibility are simple and accurate.The method can beapplied to the quality control of nine components in Xinshen’an Capsule simultaneously,which supplies another effective method for improve and perfect the quality control of Xinshen’an Capsule.