高效液相色谱法测定盐酸异苯环戊胺胶囊的含量及溶出度

发布时间：2018-04-13 23:33

  本文选题：高效液相色谱法 + 盐酸异苯环戊胺　； 参考：《国际药学研究杂志》2017年08期

【摘要】：目的建立测定盐酸异苯环戊胺胶囊含量及溶出度的方法。方法采用高效液相色谱法,色谱柱为Diamonsil C18柱(150 mm×4.6 mm,5μm);流动相为0.02 mol/L磷酸二氢钾溶液(加0.1%三乙胺,用磷酸调节pH值至3.0)-甲醇-乙腈(30∶35∶35,V/V/V);流速为1.0 ml/min;检测波长为224 nm;柱温为40℃。溶出度测定采用转篮法,分别以0.1 mol/L盐酸溶液、pH4.5醋酸盐缓冲液、水、pH 6.8磷酸盐缓冲液500 ml为溶出介质,以50、75和100 r/min为转速,筛选溶出条件。结果该法专属性良好,含量测定的线性范围为20.74~155.58μg/ml(r=1.0000),平均回收率为100.1%;溶出量测定的线性范围为2.08~24.90μg/ml(r=0.9998),平均回收率为98.9%。确定了以0.1 mol/L盐酸溶液为溶出介质和50 r/min为转速的溶出度测定方法。3批胶囊的含量和溶出度均符合规定。结论该法简便、准确、重现性好,可用于盐酸异苯环戊胺胶囊的含量及溶出度测定。
[Abstract]:Objective to establish a method for determination of isobenocyclopentylamine hydrochloride capsules content and dissolution.Methods High performance liquid chromatography (HPLC) was used. The column was Diamonsil C18 column (150mm 脳 4.6mm ~ 5 渭 m) and the mobile phase was 0.02 mol/L potassium dihydrogen phosphate solution (0.1% triethylamine, 0.1% triethylamine).The pH value was adjusted with phosphoric acid to 30: 35: 35: 35: 35 V / V / V / V, the flow rate was 1.0 ml / min, the detection wavelength was 224 nm, and the column temperature was 40 鈩，

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