枸橼酸西地那非干混悬剂溶出度测定方法的建立  

Establishment of Dissolution Determination Method for Sildenafil citrate Suspension

作　　者：陈韡彬 王娟[1] 江宁宇[1] 陈宇翔[1] 陈群 魏宗有[1] Chen Wei-bin;Wang Juan;Jiang Ning-yu;Chen Yu-xiang;Chen Qun;Wei Zong-you(Fujian Institute of Microbiology,Fuzhou,Fujian 350007,China)

机构地区：[1]福建省微生物研究所,福建福州350007

出　　处：《福建分析测试》2024年第4期4-7,共4页Fujian Analysis & Testing

基　　金：福建省属公益类科研院所基本科研专项(2021R1005003)。

摘　　要：建立枸橼酸西地那非干混悬剂的溶出度测定方法。采用桨法,以pH5.0枸橼酸-磷酸氢二钠缓冲液(Mcll-vaine缓冲液)500mL为溶出介质,转速为50r·min^(-1),用HPLC法测定枸橼酸西地那非干混悬剂的溶出度。西地那非在19.72~43.38μgmL^(-1)范围内线性关系良好,r=0.9993;平均回收率为99.3%,RSD为0.83%(n=9)。建立的方法简便、准确,可用于枸橼酸西地那非干混悬剂的溶出度测定。To establish a dissolution determination method for sildenafil citrate suspension.The dissolution of Sildenafil ci-trate suspension was determined by HPLC,and Citrate-disodium hydrogen phosphate buffer(Mcllvaine buffer,pH5.0,500 mL)was adopted as the dissolution medium in a paddle method with stirring speed at 50 r·min^(-1).Sildenafil had a good lin-ear relationship in the range of 19.72-43.38μg·mL^(-1)(r=0.9993).The average recovery were 99.3%with the RSD of 0.83%(n=9).The established method is simple and accurate,and can be used for the dissolution determination of Silde-nafil citrate suspension.

关 键 词：枸橼酸西地那非干混悬剂 溶出度 高效液相色谱法 

分 类 号：O657.72[理学—分析化学]