摘要
目的:建立一个高效、通量测定复方消化酶胶囊中熊去氧胆酸含量的高效液相色谱法。方法:选用Agilent 5HC-C_(18)色谱柱(4.6mm×250mm,5μm)测定熊去氧胆酸的含量,以0.0065mol·mL^(-1)磷酸二氢钠(用磷酸调节pH值至3.0±0.05)-甲醇-乙腈(35∶37∶28,V/V)为流动相,检测波长为210nm,流速为1.0mL·min^(-1),柱温为30℃。结果:在该条件下,熊去氧胆酸和相邻峰的分离度符合要求,样品中的熊去氧胆酸在0.1011~2.0214mg·mL^(-1)范围内浓度与其峰面积呈良好线性关系(r=1.0000),平均加样回收率为99.16%,RSD=0.55%(n=9)。该色谱方法重现性好,精密度高,供试品溶液在室温放置24h基本稳定。结论:该方法简单、快速、准确,可用于测定复方消化酶胶囊中熊去氧胆酸的含量,还可推广应用于复方消化酶胶囊中熊去氧胆酸的通量测定。
Objective:To establish a HPLC method for the determination of ursodeoxycholic acid in compound digestive enzyme capsules.Methods:The test was conducted on Agilent 5 HC-C_(18)column(4.6 mm×250 mm,5μm)with 0.0065 mol·mL^(-1)sodium dihydrogen phosphate solution(adjust pH to 3.0±0.05 with phosphoric acid),methanol and acetonitrile(35∶37∶28,V/V)as mobile phase.The detection wavelength was at 210 nm,the flow rate was 1.0 mL·min^(-1),and the column temperature was 30℃.Results:Ursodeoxycholic acid was successfully separated from adjacent peak,the resolution was 6.28(R≥1.5).The Concentration of ursodeoxycholic acid from 0.1011 to 2.0214 mg·mL^(-1)and area of the peak had a good linearity relationship(r=1.0000),and the average recovery rate was 99.16%with RSD of 0.55%,(n=9).The main features of the method are it’s good reproducibility and precision,and the test solution is basically stable at room temperature for 24 h.Conclusion:The detection method is simple,quick and accurate,which is suitable for the determination of ursodeoxycholic acid in compound digestive enzyme capsules,and the method can be applied to flux observation.
作者
叶婵娟
刘慧
罗雅
丁苏苏
Ye Chanjuan;Liu Hui;Luo Ya;Ding Susu(Yangzhou Institute for Food and Drug Control,Yangzhou 225009,China)
出处
《亚太传统医药》
2021年第4期50-52,共3页
Asia-Pacific Traditional Medicine
