磷酸奥司他韦胶囊稳定性研究

林兰,刘毅*,张才煜,袁松,黄海伟

中国药学杂志 ›› 2014, Vol. 49 ›› Issue (16) : 1458-1460.

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中国药学杂志 ›› 2014, Vol. 49 ›› Issue (16) : 1458-1460. DOI: 10.11669/cpj.2014.16.020
论著

磷酸奥司他韦胶囊稳定性研究

  • 林兰,刘毅*,张才煜,袁松,黄海伟
作者信息 +

Stability Study of Oseltamivir Phosphate Capsules

  • LIN Lan,LIU Yi*,ZHANG Cai-yu,YUAN Song, HUANG Hai-wei
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文章历史 +

摘要

目的 考察国内抗流感药品磷酸奥司他韦胶囊的质量稳定性。方法 采用高效液相色谱法(HPLC)[Phenomenex C8(2)色谱柱,流动相为0.05 mol·L-1磷酸二氢钾溶液-乙腈-甲醇(620∶135∶245),检验波长207 nm,流速1.0 mL·min-1,柱温50 ℃]对国内16批磷酸奥司他韦胶囊进行了质量稳定性研究,跟踪分析了药品储存前后及相关样本加速实验的杂质变化情况。结果 16批药品的总杂质含量储存前后分别为0.11%~0.29%和0.15%~0.71%,加速实验预测并证实了这种变化趋势。结论 国内磷酸奥司他韦胶囊药品化学质量稳定性较好,但也存在一定的差异性。

Abstract

OBJECTIVE To study the stability of domestic oseltamivir phosphate capsules. METHODS HPLC method was used to study the stability of sixteen batches of oseltamivir phosphate capsules. Phenomenex C8 (2) column was used with UV detection at 207 nm, and the mobile phase consisted of phosphoric buffer(0.05 mol·L-1 KH2PO4), methanol and acetonitrile(620∶135∶245), the flow rate was 1.0 mL·min-1, and the column oven was maintained at 50 ℃. The contents of impurities before and after storage and in accelerated condition were tracked. RESULTS The total impurity contents before and after storage were 0.11%-0.29% and 0.15%-0.71%, respectively, and the accelerated test data confirmed the change trend. CONCLUSION The domestic oseltamivir phosphate capsules are stable in chemical quality, but there exists some differences between products from different manufacturers.

关键词

磷酸奥司他韦胶囊 / 稳定性研究 / 杂质含量 / 高效液相色谱法 / 抗流感

Key words

oseltamivir phosphate capsule / stability study / impurity content / HPLC / anti-influenza

引用本文

导出引用
林兰,刘毅*,张才煜,袁松,黄海伟. 磷酸奥司他韦胶囊稳定性研究[J]. 中国药学杂志, 2014, 49(16): 1458-1460 https://doi.org/10.11669/cpj.2014.16.020
LIN Lan,LIU Yi*,ZHANG Cai-yu,YUAN Song, HUANG Hai-wei. Stability Study of Oseltamivir Phosphate Capsules[J]. Chinese Pharmaceutical Journal, 2014, 49(16): 1458-1460 https://doi.org/10.11669/cpj.2014.16.020
中图分类号: R917   

参考文献

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基金

国家质量监督检验检疫总局公益性行业科研专项(20124244008-10)
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