盐酸氮卓斯汀片溶出度测定方法的研究

目的：建立盐酸氮卓斯汀片溶出度的测定方法。方法：采用小杯法，以0．1mol／L盐酸100ml为溶剂，转速100转／min,经30min取样。用高效液相色谱法测定溶出量，以十八烷基硅烷键合硅胶为填充剂；4％_二乙胺（用醋酸调节pH值至6．0）-乙腈-甲醇（45：20：35）为流动相；检测波长为290nm；流速lml／min；进样量20μl，外标法定量。结果：方法的平均同收率为100．6％，R5D=1．80％；回归方程为A=19121C-3236，r=0．9999，线性范围为5-200wg／ml。三批样品的累积溶出曲线显示，在30min时溶出已达90％以上，45min时溶出趋向完全。溶出均一性实验显示，每批6片6个测定时间点溶出量平均值的RSD均为1．5％～7．5％。结论：本方法准确可靠，适用于该制剂的质量控制。

Study on the method of dissolution determination for Axeiatine Hydrochloride Tablets

Objective：To establish the method of dissolution determination for Axeiatine Hydrochloride Tablets. Methods： The experiment was carried out in small glass method. The medium was 0.1 mol/L HC1 100 ml. The rotational speed was 100 r/min.Sampling at 30 rain. The determination method was HPLC. The column was diamonsil ODS-C18, mobile phase was 4% triethylamine （adjusting the pH to 6.0 by acetic acid） -acetonitrile-methanol （45：20：35）. The flow rate was set at lml/min,detection wavelength was set at 290 nm. Results： The average recovery for axeiatine hydrochloride was 100.6% with RSD of 1.8%.The calibration curve was linear in the range of 5～200 ptg/ml with correlation coefficient of 0.999 9.The result of accumulation dissolution of three bitch Axeiatine Hydrochloride Tablets showed the dissolution amount was 90% at 30 rain and about 100% at 45 rain. The test of dissolution uniformity indicated the RSD of average dissolution amount was between 1,5%～7.5% at 6 determination point with 6 tablets. Conclusion：The method is accurate and suitable for dis- solution determination for Axeiatine Hydrochloride Tablets.