摘要
建立苯溴马隆胶囊溶出度测定的不确定度评定方法,考察溶出度测定的影响因素。利用建立的数学模型,可知溶出度测定的不确定度来源包括苯溴马隆对照品的纯度和称样量、对照品溶液的体积、样品溶液体积、样品的重复性测定及紫外-可见分光光度计测量偏差。结果表明,苯溴马隆胶囊平均溶出量为106.2%时,扩展不确定度为2.9%(k=2)。不确定度来源主要为对照品的称样量和样品的重复性测定。测量过程中通过降低对照品称量误差、选择经过校准且精度较高的玻璃量器并加强紫外-可见分光光度计的定期维护保养,以提高测定结果的准确性。
The influencing factors of dissolution test of benzbromarone capsules were investigated by the evaluation of the uncertainty.According to the mathematical model established,the sources of uncertainty in the dissolution test included the purity and the weight of benzbromarone reference standard,the volume of the reference and sample solution,the repeatability of the sample and the measurement deviation of the ultraviolet-visible spectrophotometry.The results indicated that the expanded uncertainty was 2.9%(k=2)when the average dissolution amount was 106.2%.The main sources of uncertainty were the weight of reference standard and the repeatability of the sample.Trough reducing weighing error of the reference standard,selecting the calibrated and high-precision glass measuring instruments,and strengthening the regular maintenance and upkeep of ultraviolet-visible spectrophotometry,so as to improve the accuracy and reliability of the testing results.
作者
吴静芳
李玮玲
WU Jingfang;LI Weiling(Guangzhou Institute for Drug Control,Guangzhou 510160,China)
出处
《山东化工》
2024年第24期135-137,共3页
Shandong Chemical Industry
关键词
苯溴马隆胶囊
溶出度
紫外-可见分光光度法
不确定度评定
benzbromarone capsules
dissolution
ultraviolet-visible spectrophotometry
uncertainty evaluation
