司莫司汀胶囊溶出度测定方法的研究

目的:建立测定司莫司汀胶囊溶出度的方法。方法:溶出试验方法采用桨法,以900 ml 2.5%十二烷基硫酸钠溶液(p H=6.0)为溶出介质,转速为75 r/min;含量测定采用高效液相色谱法,色谱柱为Agilent C18,流动相为甲醇-水(70∶30),检测波长为232nm。结果:司莫司汀质量浓度线性范围为10¹00μg/ml(r=0.999 9),平均回收率为99.92%100μg/ml(r=0.999 9),平均回收率为99.92%¹00.99%,RSD<0.60%(n=6)。3批胶囊45 min内累积溶出量为69.9%100.99%,RSD<0.60%(n=6)。3批胶囊45 min内累积溶出量为69.9%⁷2.4%。结论:本方法符合溶出度方法的建立原则,可控制司莫司汀胶囊的内在质量;同时建议在该制剂的现行国家标准中增加溶出度检查项目。

Method Study for the Dissolution Determination of Semustine Capsules

OBJECTIVE：To establish a method for the dissolution determination of Semustine capsules. METHODS：Paddle method was used to determine dissolution rate using 900 ml 2.5% sodium dodecyl sulfate solution（p H=6.0）as medium with rotation speed of 75 r/min. HPLC method was adopted. Agilent C18 column was used with mobile phase consisted of methanol-water（70 ∶ 30）;the detection wavelength was set at 232 nm. RESULTS：The linear range of semustine was 10-100 μg/ml（r=0.999 9）with average recoveries of 99.92%-100.99%（RSD〈0.60%,n=6）. The accumulative dissolution of 3 batches of samples was69.9%-72.4% within 45 min. CONCLUSIONS：The method is in line with the principle for the dissolution test method,and can effectively control the internal quality of product. It is suggested to add dissolution test item into present national standard for the preparation.