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HPLC法测定头孢克洛颗粒中头孢克洛及其异构体

江月华,陈懂,林红   

  1. 浙江万邦药业股份有限公司,浙江万邦药业股份有限公司,浙江万邦药业股份有限公司
  • 收稿日期:2013-04-16 修回日期:2013-04-16 出版日期:2013-04-25 发布日期:2013-04-25

Determination of Cefaclor Granules’s Retalated Substance by Hplc

jiangyuehua,chendong and linhong   

  1. Zhejiang Wanbang pharmaceutical Limited by Share Ltd,Zhejiang Wanbang pharmaceutical Limited by Share Ltd,Zhejiang Wanbang pharmaceutical Limited by Share Ltd
  • Received:2013-04-16 Revised:2013-04-16 Online:2013-04-25 Published:2013-04-25

摘要: 目的 建立HPLC法测定头孢克洛颗粒中头孢克洛及其异构体。方法 采用P/NO.OOG-4435-EO Desc.Gemini 5μ C18 110A Size 250﹡4.60mm 5 micron S/NO.490274-28柱,柱温35℃;流动相A为0.78%磷酸二氢钠溶液,流动相B为0.78%磷酸二氢钠溶液(pH4.0)-乙腈(55:45);检测波长220nm;流速1.0mL.min-1;线性梯度洗脱。结果 最低检测限为1.02ng。结论 本方法灵敏、精密度高、专属性强,可用于头孢克洛颗粒中头孢克洛及其异构体。

Abstract: OBJECTIVE To establish a reversed-phase Hplc method for the determinination of the cefaclor granules’s cefaclor and its isomers. METHODS The analytical column was P/NO.OOG-4435-EO Desc.Gemini 5μ C18 110A Size 250﹡4.60mm 5 micron S/NO.490274-28 and the column temperature was maintained at 35℃. The mobile phase A was 0.78% sodium dihydrogen phosphate acid ,the mobile phase B was 0.78% sodium dihydrogen phosphate acid(pH4.0)-acetonitrile(55:45). The detertion wavelength was 253nm.The flow rate was 1.0mL?min-1 and linear gradient elution. RESULTS The limit of detection was 1.02ng.CONCLUSION The method is proved to be sensitive and prwcise andshowed highlyspecific.It can be applied for cefaclor and its isomers of cefaclor granules.