复方降压片中利血平溶出度测定方法的研究

Research on the determination of the dissolution of reserpine in compound antihypertension tablets

目的 :建立复方降压片中利血平的溶出度测定方法。方法 :依照《中国药典》2 0 0 0年版二部附录溶出度项下第三法 ,以正丙醇 - 0 .1mol/ L 盐酸 (3∶ 7)为溶出介质 ,转速为 10 0 r/ min,高效液相色谱法检测 ,检测波长为 2 6 8nm。结果 :在 0 .0 6 4～ 0 .2 5 6 μg/ ml范围内 (r=0 .9997) ,浓度与峰面积呈良好的线性关系 ,平均回收率为 10 0 .2 % ,RSD为 1.0 %。结论 :该法操作简便 ,准确可靠。

Object: To establish a method for the determination of the dissolution of reserpine in compound antihypertension tablets. Methods: The dissolution test was carried out according to the pharmacopoeia of the Peoples Republic of China (Edition 2000, volume 2, Appendix method 3) by using propanol-0.1 mol/L hydrochloric acid (3∶7) as the solvent, with the rotation speed adjusted to 100 r/min. An HPLC method was used for the determination and the detection wavelength was set at 268 nm. Results: There was a good linearity for reserpine within the range of 0.064～0.256 μg/ml (r=0.999 7), the average recovery was 100.2% with RSD of 1.0%. Conclusion: This method was simple, accurate and precise.