RP-HPLC测定骨筋丸胶囊中羟基红花黄色素A、落干酸和龙胆苦苷的含量  

Determination of hydroxysafflor yellow A,loganic acid and gentiopicroside in Gujinwan capsules by RP- HPLC

作　　者：杨红 陈岳蓉 刘海青 

机构地区：[1]山西药科职业学院,太原030031 [2]青海省食品药品检验所,西宁810000

出　　处：《药物分析杂志》2014年第3期423-427,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立HPLC法测定骨筋丸胶囊中羟基红花黄色素A、落干酸和龙胆苦苷含量。方法：测定羟基红花黄色素A，采用EclipseXDB—C18色谱柱（250mm×4．6mm，5μm），以甲醇-水-磷酸（27：73：0．05）为流动相，流速1．0mL·min^-1，检测波长403nm，柱温为室温（20℃）；测定落干酸和龙胆苦苷，采用EclipseXDB—C18色谱柱（250mm×4．6mm，5μm），以乙腈-水（10：90，醋酸调pH2．5）为流动相，流速1．0mL·min^-1，检测波长250nm，柱温35℃。结果：羟基红花黄色素A、落干酸和龙胆苦苷的线性范围分别为0．014～0．288μg（r=0．9995）、0．056。1．120μg（r=0．9998）和0．114～2．284μg（r=0．9997），平均加样回收率（n=9）分别为98．8％、99．8％和99．3％。结论：所建立的方法经方法学验证快速简便，重复性好，专属性强，可作为中药制剂骨筋丸胶囊的质量控制方法。Objective：To develop HPLC methods for the content determination of hydroxysafflor yellow A, loganic acid and gentiopicroside in Gujinwan capsules. Methods： The separation was performed on Eclipse XDB - C18 column （250 mm x 4. 6 mm, 5 μm） at room temperature （20 % ）. The mobile phase was composed of methanol - water - phosphoric acid （27： 73： 0. 05） for the determination of hydroxysafflor yellow A at a flow rate of 1.0 mL^-1 rain-1 ,and the detection wavelength was at 403 nm. The separation was performed on Eclipse XDB -Clscolumn （250 mm x4. 6 ram,5 μm） at 35 ℃. The mobile phase was composed of acetonitrile -water （10： 90, adjusted pH to 2. 5 with acetic acid） for the determination of loganic acid and gentiopicroside at a flow rate of 1.0 mL · min-1, and the detection wavelength was at 250 nm. Results： The calibration curves were linear within the range of 0. 014 - 0. 288 μg （ r = 0. 9995 ） ,0. 056 - 1. 120 μg （ r = 0. 9998 ） acid and gentiopicroside,respectively. The and 0. 114 - 2. 284 txg （ r = 0. 9997 ） for hydroxysafflor yellow A, loganic average recoveries were 98. 8% ,99. 8% and 99. 3% for hydroxysafflor yellow A,loganic acid and gentiopicroside ,respectively. Conclusion： The method is applicable for the determination ysafflor yellow A,loganic acid and gentiopicroside in Gujinwan capsules by methodology validation of hydroxysafflor yellow A,loganic acid and gentiopicroside in Gujinwan capsules by methodology validation

关 键 词：骨筋丸胶囊 羟基红花黄色素A 落干酸 龙胆苦苷 方法验证 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]