HPLC测定小儿柴葛口服液原方中10种成分含量

Content Assay of 10 Components in Original Prescription of Xiaoer Chaige Oral Solution by HPLC

目的:建立小儿柴葛口服液原方中3′-羟基葛根素、3′-甲氧基葛根素、葛根素、芍药苷、芍药内酯苷、汉黄芩苷、黄芩苷、甘草苷、柴胡皂苷a、柴胡皂苷b 2的含量测定方法。方法:采用Agilent TC-C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈(A)-0.1%磷酸水溶液(B),梯度洗脱,流速为1.0 mL·min^-1,柱温为30℃,检测波长为230、210 nm。结果:该方法的专属性良好,精密度、重复性和稳定性的RSD均小于2%;3′-羟基葛根素、3′-甲氧基葛根素、葛根素、芍药苷、芍药内酯苷、汉黄芩苷、黄芩苷、甘草苷、柴胡皂苷a、柴胡皂苷b 2分别在0.005~0.078、0.010~0.163、0.038~0.603、0.014~0.226、0.004~0.052、0.011~0.170、0.049~0.780、0.003~0.046、0.006~0.092、0.002~0.036 mg·mL^-1呈良好线性关系;在测定的3批样品中上述化合物的平均质量分数分别为1.41、2.85、11.06、3.47、1.35、2.88、13.60、0.73、3.13、1.18 mg·g^-1。结论:该方法简便,易操作,重复性好,可用于小儿柴葛口服液原方中10种主要成分的含量测定。

Objective:To establish a content assay method for 3′-hydroxypuerarin,3′-methoxypuerarin,puerarin,paeoniflorin,albiflorin,wogonoside,baicalin,liquiritin,saikosaponin a and saikosaponin b 2 in the original prescription of Xiaoer Chaige Oral Solution.Methods:HPLC analysis was performed on an Agilent TC-C 18 column(250 mm×4.6 mm,5μm)with gradient elution using acetonitrile as mobile phase A and 0.1%aqueous phosphoric acid as mobile phase B at the flow rate of 1.0 mL·min^-1 and column temperature of 30℃under detection wavelength of 230 nm and 210 nm.Results:The method was specific,and its RSDs for precision,repeatability and stability were all less than 2%.3′-hydroxypuerarin,3′-methoxypuerarin,puerarin,paeoniflorin,albiflorin,wogonoside,baicalin,liquiritin,saikosaponin a and saikosaponin b 2 showed good linear relationship in the range of 0.005-0.078,0.010-0.163,0.038-0.603,0.014-0.226,0.004-0.052,0.011-0.170,0.049-0.780,0.003-0.046,0.006-0.092 and 0.002-0.036 mg·mL^-1.The average contents of the above compounds in three batches of samples determined were 1.41,2.85,11.06,3.47,1.35,2.88,13.60,0.73,3.13 and 1.18 mg·g^-1,respectively.Conclusion:This method is simple,easy to operate and well repeatable,thereby it can be used for the content determination of ten major components in the original prescription of Xiaoer Chaige Oral Solution.