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

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、pH 4.5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.

HPLC determination of the content and dissolution of isophenylcyclopentylamine hydrochloride capsules

Objective To establish a method for the determination of the content and dissolution of isophenylcyclopentyl?amine hydrochloride capsules. Methods The HPLC analysis was performed on a Diamonsil C18 column(150 mm×4.6 mm,5μm). A mixture of 0.02 mol/L KH2PO4 solution containing 0.1%triethylamine with pH adjusted to 3.0 by phosphoric acid-methanol-acetonitrile (30:35:35)was used as the mobile phase with the flow rate at 1.0 ml/min. The detection wavelength was 224 nm. Dissolution was de?termined by the basket method,using the 500 ml of 0.1 mol/L hydrochloric acid solution,pH 4.5 acetic acid buffer,water and pH 6.8 phosphoric acid buffer as dissolution media under the 50,75 and 100 r/min rotation speeds to select the dissolution condition. Re?sults This method had high specificity. The linear range for the quantitative determination was 20.74-155.58 μg/ml(r=1.0000), and the average recovery was 100.1%. The linear range for the determination of dissolution was 2.08-24.90μg/ml(r=0.9998),with the average recovery of 98.9%. The method of dissolution tests was established:0.1 mol/L hydrochloric acid solution was used as disso?lution medium and rotation speed was 50 r/min. The determined content and dissolution of three batches of capsules fulfilled the re?quirements. Conclusion The method is simple,accurate and reproducible for the determination of the content and dissolution of iso?phenylcyclopentylamine hydrochloride capsules.