【作者】 陈有钟； 黄捷； 余辉； 王建民； 王晋； 程元荣；

【Author】 Chen You-zhong,Huang Jie,Yu Hui,Wang Jian-min,Wang Jin,Cheng Yuan-rong (FuJian Institute of Microbiology,Fuzhou 350007)

【机构】 福建省微生物研究所；

【摘要】 目的建立西罗莫司片的质量控制方法,评价西罗莫司片质量。方法采用高效液相色谱法测定西罗莫司含量、有关物质,用紫外分光光度法测定西罗莫司片的溶出。结果在高效液相色谱法含量测定中,西罗莫司在50-300μg·mL^-1范围线性良好,平均回收率为98.92%,RSD为0.69%;在紫外分光光度法西罗莫司片溶出测定中,西罗莫司在0.25-15μg·mL^-1范围线性良好,平均回收率为99.28%,RSD分别为0.70%。结论本品质量控制方法结果准确,有效地控制西罗莫司片质量。更多还原

【Abstract】 Objective:To establish quality control method of sirolimus tablets.Methods: The content of sirolimus tablets was determined by HPLC and the dissolution of sirolimus tablets was determined by UV spectrophotometry.Results:A good linear relationship was obtained in the range of 50-300μg·mL^-1 as determined by HPLC,the average recovery of sample was 98.92%,and RSD was 0.69%respectively.A good linear relationship was obtained in the range of 0.25-15μg·mL^-1 as determined by UV spectrophotometry,the average recovery of sample was 99.28%,and RSD was 0.70%respectively.Conclusions:The reliable quality control method was achieved.更多还原