摘要
建立熊去氧胆酸胶囊中有关物质的含量测定方法。采用高效液相色谱法,色谱柱为Merck Super—spher 100 RP-18;流动相为乙腈-0.001 mol/L磷酸二氢钾溶液(50:50)(用磷酸调pH2.0);流速1.2 ml/min; 检测波长为205 nm;柱温40℃。熊去氧胆酸胶囊中有关物质胆酸、7-酮基胆石酸、鹅去氧胆酸、胆石酸在25 min 内洗脱并完全分离。胆酸在0.138 9-0.277 7mg/ml间线性关系良好,r=1.000 0,进样浓度为0.013 89mg/ml 时仍能检出;7-酮基胆石酸0.106 7 -0.213 5 mg/ml间线性关系良好,r=1.000 0,进样浓度为0.010 67 mg/ml 时仍能检出;鹅去氧胆酸在0.264 3-0.528 5 mg/ml间线性关系良好,r=1.000 0,进样浓度为0.026 43 mg/ml 时仍能检出;胆石酸在0.026 86-0.053 72 mg/ml间线性关系良好,r=1.000 0,进样浓度为0.006 71 mg/ml时仍能检出。方法回收率、精密度均符合要求。本法操作简便,结果准确可靠,适用于熊去氧胆酸胶囊中上述有关物质的含量测定。
To establish a HPLC method for the determination of cholic acid, 7-ketolithocholic acid,chenodeoxycholic acid and lithocholic acid in Ursodeoxycholic Acid Capsules. The HPLC separation was performed on a Merck Superspher 100RP-18 125 4, with the mobile phase of Acetonitrile-0. 001 mol/L potassium dihydrogen phosphate solution （50：50）（abjust pH2.0 with HaPO4）; flow rate： 1.2 ml/min; at the detection wavelength of 205 nm. The linear ranged from 0. 138 9-0. 277 7 mg/ml（r=1.000 0） for cholic acid, from 0. 106 7-0. 2135mg/ml（r=1.000 0） for 7-ketolithocholic acid,from 0. 264 3-0. 5285mg/ml（r=1.000 0） for chenodeoxycholic acid and from 0. 02686-0. 053 72mg/ml （r=1.000 0）for lithocholic acid. The established method is simple and accurate. It can be applied to determine cholic acid, 7-ketolithocholic acid, chenodeoxycholic acid and lithocholic acid in Ursodeoxycholic Acid Capsule.
出处
《药物生物技术》
CAS
CSCD
2005年第4期248-250,共3页
Pharmaceutical Biotechnology
关键词
高效液相色谱法
熊去氧胆酸胶囊
有关物质
HPLC, Ursodeoxycholic Acid Capsul,Related substance, Determination of content
