泛昔洛韦制剂含量测定方法研究

Study on Content Determination of Famciclovir in Tablets and Capsules

目的建立泛昔韦洛制剂含量测定方法。方法采用吸收系数(E1%1cm)法在305nm波长处测定泛昔洛韦制剂的含量。结果泛昔洛韦质量浓度在5～35μg/mL范围内与吸光度线性关系良好。片剂的平均回收率为100.28%,RSD=0.5%(n=9);胶囊剂的平均回收率为99.93%,RSD=0.2%(n=9)。与紫外对照品法和高效液相色谱(HPLC)法比较,测得的3批片剂样品与3批胶囊剂样品的含量基本一致。结论所建方法操作简便、快速、灵敏,可用于药厂及医院药房的质量控制。

Objective To establish a method for the determination of famciclovir in tablet and capsule. Methods The absorption coefficient （E^1%1cm）method was used, The detection wavelength was at 305 nm. Results The calibration curve was linear in the range of 5-35μg/mL. The recovery rate was 100.28% for the tablets, RSD =0.5% （ n = 9） and 99.93% for the capsules, RSD =0.2% （n=9）, The determined content in 3 batch of tablets and capsules by the absoption coefficient method was compared with that by UV and HPLC. The results were basically in agreement. Conclusion The method is stable, simple and accurate, It can be used for the quality control of famciclovir.