HPLC法同时测定利胆解毒胶囊中獐牙菜苦苷和龙胆苦苷的含量  

Simultaneous determination of swertiamain and gentiopicrin in Lidan Jiedu Capsules by HPLC

作　　者：杨深应 吉翠莲 陶明宝 沈红春 尹兴章 YANG Shenying;JI Cuilian;TAO Mingbao;SHEN Hongchun;YIN Xingzhang(Baoshan Inspection and Testing Center for Food and Drug,Baoshan 678000,China;Yunnan Longfa Pharmaceutical Co.,Ltd.,Chuxiong 675000,China)

机构地区：[1]保山市食品药品检验检测中心,云南保山678000 [2]云南龙发制药股份有限公司,云南楚雄675000

出　　处：《中国药品标准》2020年第5期414-417,共4页Drug Standards of China

摘　　要：目的:建立高效液相色谱法(HPLC)同时测定利胆解毒胶囊中獐牙菜苦苷和龙胆苦苷含量的方法。方法:采用Agilent 5 TC-C 18(2)色谱柱(4.6 mm×250 mm,5μm),流动相为甲醇-水(20∶80),流速1.0 mL·min-1,检测波长254 nm,柱温30.0℃。结果:獐牙菜苦苷、龙胆苦苷线性范围分别为0.1181~1.1807μg(r=0.99996)和0.0914~0.9141μg(r=0.99993);平均回收率分别为98.85%和97.12%,RSD分别为0.49%和0.61%。测定4批样品,结果每粒含獐牙菜苦苷和龙胆苦苷的含量分别在4.51~4.90 mg和3.34~3.47 mg之间。结论:该方法操作简便、重复性好、结果准确,可作为利胆解毒胶囊质量的控制方法。Objective:To establish an HPLC method for the simultaneous determination of swertiamain and gentiopicrin in Lidan Jiedu Capsules.Method:The test was performed in Agilent 5 TC-C 18(2)column(4.6 mm×250 mm,5μm)under the isocratic elution of methanol-water(20∶80).The flow rate was 1.0 mL·min-1,the detection wavelength was 254 nm,and the column temperature was 30.0℃.Results:The linear ranges of swertiamain and gentiopicrin fell into 0.1181-1.1807μg(r=0.99996)and 0.0914-0.9141μg(r=0.99993)respectively,and the average recovery were 98.85%and 97.12%with RSD as 0.49%and 0.61%,respectively.The test results of 4 batches of samples showed that the contents of swertiamain and gentiopicrin fell into 4.51-4.90 mg per capsule and 3.34-3.47 mg per capsule respectively.Conclusion:The established method has the simple operation,good repeatability and accuracy.It can be used for quality control of Lidan Jiedu Capsules.

关 键 词：利胆解毒胶囊 獐牙菜苦苷 龙胆苦苷 高效液相色谱法 含量测定 

分 类 号：R921.2[医药卫生—药学]