苯磺酸左旋氨氯地平片溶出度检查方法验证  

Validation of Dissolution Method of Levamlodipine Besylate Tablets

作　　者：陈燕 

机构地区：[1]浙江绍兴柯桥区药品检验检测中心,柯桥312030

出　　处：《海峡药学》2016年第1期15-17,共3页Strait Pharmaceutical Journal

摘　　要：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200m L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·m L-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。OBJECTIVE To validate the dissolution method of Levamlodipine besylate tablet. METHODSDissolution method in the The national drug standard WSI-（ X-020 ）-2002Z was used. Dissolution medium was 0. lmol · L-1 HC1 solution 200mL and rotational speed was 50r · min-1. After 30min the dissolution solution was taken and analyzed by ultraviolet-visible spectrophotometry at the wavelength of 238nm. RESULTS The linear relationship 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.

关 键 词：苯磺酸左旋氨氯地平片 溶出度 方法学验证 紫外分光光度法 

分 类 号：R927[医药卫生—药学]