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舒马曲坦胶囊的制备与质量控制
引用本文:张敬如,赵凯,黄复生,王昆. 舒马曲坦胶囊的制备与质量控制[J]. 中国药业, 2012, 21(21): 32-34
作者姓名:张敬如  赵凯  黄复生  王昆
作者单位:中国人民解放军第三军医大学基础部病原生物学教研室,重庆400038
基金项目:重庆市基金面上项目,项目编号:CSTC2010BB5168
摘    要:目的制备舒马曲坦胶囊并建立其质量控制方法。方法采用高效液相色谱(HPLC)法测定制剂中舒马曲坦。结果舒马曲坦质量浓度在50~1 600 ng/mL范围内与峰面积线性关系良好(r=0.999 9),平均回收率为(105.73±4.58)%,RSD为4.33%(n=6),日内、日间精密度平均RSD为2.20%和2.59%。结论质量控制方法稳定可靠,可用于舒马曲坦胶囊的质量控制。

关 键 词:舒马曲坦胶囊  质量控制  高效液相色谱法

Preparation and Quality Control of Sumatriptan Capsule
Zhang Jingru,Zhao Kai,Huang Fusheng,Wang Kun. Preparation and Quality Control of Sumatriptan Capsule[J]. China Pharmaceuticals, 2012, 21(21): 32-34
Authors:Zhang Jingru  Zhao Kai  Huang Fusheng  Wang Kun
Affiliation:(Department of Pathogenic Biology, Third Military Medical University, Chongqing, China 400038)
Abstract:Objective To prepare sumatriptan capsules and establish the quality standard for them. Methods HPLC was used to deter-mine the content of sumatriptan. Results Sumatriptan showed a good linear relationship in the range of 50-1 600 ng/mL(r =0. 999 9) and the average recovery was up to (105.73±4.58)%, RSD was 4. 33%.The mean intra-day RSD and inter-day RSD were 2.20% and 2.59%. Conclusion This standard is precise and can be used for the quality control of sumatriptan capsules.
Keywords:Sumatriptan Capsules  quality control  HPLC
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