萘丁美酮分散片的制备与含量测定
China Pharmaceuticals(2009)
Abstract
目的制备萘丁美酮分散片并建立其含量测定方法。方法通过正交试验考察处方中组分的影响因素,以崩解时限为指标对萘丁美酮分散片处方进行优选;用高效液相色谱(HPLC)法测定分散片中萘丁美酮的含量。结果最佳处方为羧甲基淀粉钠6%,十二烷基硫酸钠1%,微晶纤维素10%,聚乙烯吡咯烷酮浓度2%;优选处方的分散片崩解时间小于3min,分散均匀,均通过2目筛;萘丁美酮质量浓度线性范围为20~100μg/mL,r=0.9999(n=5),平均回收率为99.54%,RSD=0.48%(n=6)。结论用优选处方制备的萘丁美酮分散片崩解快,分散均匀,且含量测定结果符合限度要求。
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Key words
HPLC,orthogonal design,Nabumetone Dispersible Tablets
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