摘要
目的建立阿折地平片的溶出度测定方法,并对其进行方法学验证。方法采用紫外分光光度法测定阿折地平片溶出度。对其进行检测波长的选择;膜吸附情况的考察;并且考察阿折地平在不同转速(50 r/min、100 r/min、150 r/min)、不同介质(蒸馏水,p H 1.0盐酸溶液,p H 2.0盐酸溶液,p H 6.8缓冲盐溶液)、不同溶出度方法(桨法、篮法)下的溶出度,并对方法的回收率、线性、溶液稳定性、重复性等进行考察。结果方法学研究结果表明:紫外分光光度法测定阿折地平片的最大吸收波长为270.8 nm;药物不受膜吸附的影响,选择p H1.0盐酸为溶出介质;选择桨法100 r/min为实验方法 ;实验结果表明,空白辅料在最大吸收波长处不干扰阿折地平片的测定;线性范围为4μg/ml^40μg/ml;溶出度方法的平均回收率为99.87%(RSD=0.43%,n=9);样品溶液在0~15小时内溶液稳定性良好。结论实验所建立的溶出度测定方法,经方法学验证表明其专属性强、灵敏度高,精确度和准确度符合测定要求,操作简单,可准确测定阿折地平片的溶出度。
Objective To establish a method for testing the dissolution of Azelnidipine tablets. Methods Ultraviolet spectrophotometry was used to identify the method of dissolution of Azelnidipine tablets at different speeds（50 r/min, 100 r/min, 150 r/min）, in different media（distilled water, p H 1.0 HCL solution, p H 2.0 HCL solution, p H 6.8 buffer solution） and in different release method（paddle method and basket method）. Besides, the determined wave-length, the absorption of the membrane, the recovery, linearity and stability of the solution were investigated. Results In this study, wavelength of ultraviolet absorption was determined at 270.8 nm, the method of dissolution of Azelnidipine tablets was that： paddle method was adopted, using 0.1 mol/L hydrochloric acid as dissolution medium, the speed was at 100 r/min. The assay displayed a good linearity over the concentration range of 4~40 μg/ml. The average recoveries were 99.87%（RSD=0.43%, n=9）, sample solution was stable within 0~15 hour. Conclusion The method established is simple, accurate and repeatable for the quality control of Azelnidipine tablets.
出处
《继续医学教育》
2016年第4期160-162,共3页
Continuing Medical Education
