人工牛黄甲硝唑胶囊中主要胆汁酸类成分的HPLC-ELSD法测定研究

发布时间：2018-08-07 22:00

【摘要】：目的:建立同时测定人工牛黄甲硝唑胶囊中来源于原料人工牛黄中的5种胆汁酸类成分(牛磺胆酸钠、胆酸、猪去氧胆酸、鹅去氧胆酸和去氧胆酸)的方法。方法:采用高效液相色谱仪与蒸发光散射检测器联用技术对人工牛黄甲硝唑胶囊进行测定。色谱条件:Agilent TC-C18色谱柱(4.6 mm×250 mm,5μm),柱温35℃;流动相为0.2%甲酸水溶液(A)-乙腈(B),梯度洗脱(0~10 min,15%B→32%B;10~15 min,32%B→50%B;15~22 min,50%B→68%B;22~23 min,68%B→95%B;23~28 min,95%B),流速1.0 m L·min-1;ELSD检测器:氮气流速2.3 L·min-1,漂移管温度115℃。结果:牛磺胆酸钠、胆酸、猪去氧胆酸、鹅去氧胆酸、去氧胆酸质量浓度分别在24.93~249.27、47.62~476.19、39.72-397.23、6.29~62.92和10.63~106.28μg·m L-1范围内与峰面积成良好对数线性关系;平均回收率(n=6)分别为99.9%(RSD=1.6%)、98.9%(RSD=1.6%)、99.2%(RSD=2.0%)、99.4%(RSD=2.0%)和98.6%(RSD=2.0%);3批样品测定结果分别为0.16%~0.37%、0.67%~0.75%、0.44%~0.70%、0.10%~0.17%、0.16%~0.19%。结论:该法可同时测定人工牛黄甲硝唑胶囊中来源于原料人工牛黄的5种胆汁酸类成分(牛磺胆酸钠、胆酸、猪去氧胆酸、鹅去氧胆酸和去氧胆酸)的含量,适用于人工牛黄甲硝唑胶囊的质量评价与控制。
[Abstract]:Objective: to establish a method for simultaneous determination of five kinds of bile acids (sodium taurocholate, cholic acid, porcine deoxycholic acid, chenodeoxycholic acid and deoxycholic acid) in Metronidazole capsules. Methods: the method of high performance liquid chromatograph and evaporative light scattering detector was used to determine the artificial bezoar metronidazole capsules. The mobile phase consisted of 0.2% formic acid aqueous solution (A) and acetonitrile (B), gradient elution (0.10 min ~ 15B ~ 15B ~ 1015 min) with a column temperature of 4.6mm 脳 250mm ~ 5 渭 m),. The mobile phase consisted of a flow rate of 1.0 mL 路min -1 ELSD detector: nitrogen flow rate 2.3 L -1, drift tube temperature 115 鈩，

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