苯磺酸左旋氨氯地平片溶出度检查方法验证

摘要

ABSTRACT:OBJECTIVE To validate the dissolution method of Levamlodipine besylate tablet .METHODS Dissolution method in the The national drug standard WS 1-( X-020 )-2002 Z was used.Dissolution medium was 0.1 mol・ L-1 HCl solution 200 mL and rotational speed was 50 r・ min-1 .After 30 min the dissolution solution was taken and analyzed by ultraviolet-visible spectrophotometry at the wavelength of 238 nm.RESULTS The linear rela-tionship was in the range of 6.9738~27.8954μg・ mL-1(r=1),the sample stability and dissolution uniformity were good.CONCLUSION The method was consistent with the principle of the determination of dissolution .The opera-tion was simple ,accurate and could be used as a method of quality control .%目的：验证苯磺酸左旋氨氯地平片溶出度的检查方法。方法采用国家药品标准WS1－（X－020）－2002Z规定的方法，通过紫外分光光度法，以0．1mol・ L－1盐酸溶液200mL为溶出介质，转速50r・ min －1，经30min时，在波长238nm处测定吸光度。结果浓度与吸光度在6．9738～27．8954μg・ mL －1范围内呈良好线性，r＝1，样品稳定性与溶出均一性好。结论本方法符合溶出度方法的建立原则，操作简单，准确，可控制苯磺酸左旋氨氯地平片的内在质量。