RP-HPLC法测定5种剂型的九味羌活制剂中紫花前胡苷、异欧前胡素

Determination of nodakenin and isoimperatorin in five kinds of Jiuwei Qianghuo preparation by RP-HPLC

目的建立九味羌活（羌活、防风、苍术、黄芩、川芎、白芷、地黄、细辛和甘草）5种不同剂型（大蜜丸、小蜜丸、浓缩丸、水丸、颗粒剂）中紫花前胡苷和异欧前胡素的测定方法。方法 HPLC分析采用Diamonsil C18色谱柱（4.6 mm×250 mm,5μm）;乙腈-0.5%冰乙酸水溶液为流动相,非线性梯度洗脱;柱温30℃;体积流量1.0 mL/min;检测波长330 nm。结果采用的方法对5种剂型中紫花前胡苷和异欧前胡素的测定均适用,其中紫花前胡苷在9.38～469.20 ng、异欧前胡素在12.56～167.48 ng范围内线性良好,相关系数均为0.999 9。结论本法分离效果好,专属性强,准确,可用于九味羌活系列制剂的质量控制。

AIM To develop an HPLC method for determining nodakenin and isoimperatorin in five kinds of Jiuwei Qianghuo preparation（ Notopterygii Rhizoma et Radix, Saposhnikoviae Radix, Atractylodis Rhizoma,Scutelarxae Radix,Chuanxiong Rhizoma,Angelicae dahuricae Radix,Rehmanniae Radix,Asari Radix et Rhizma,Glycyrrhizae Radix et Rhizoma）,including major and minor honeyed pills,concentrated pills,water pills,and granules. METHODS The analysis was performed on diamonsil C18column（ 250 mm × 4. 6 mm,5 μm）with the mobile phase consisted of acetonitrile-0. 5% acetic acid in nonlinear gradient elution manner. The flow rate was 1. 0 mL /min,the column temperature was maintained at 30 ℃ and the detection wavelength was set up at330 nm. RESULTS The linear ranges of nodakenin and isoimperatorin were 9. 38 ～ 469. 20 ng,12. 56 ～167. 48 ng,respectively. Both the correlation coefficient were more than 0. 999 9. CONCLUSION The method is accurate,reliable. It can be used as the quality control of Jiuwei Qianghuo preparations.