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注射用头孢他啶分装设备冲洗液的检测方法研究 被引量:2

Studiy on Analytical Method of Rinse Water to Equipment of Packing Separately Ceftazidime for Injection
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摘要 目的:建立注射用头孢他啶的分装设备的冲洗液的检测方法,控制冲洗液中头孢他啶的残留量。方法:紫外—可见分光光度法,检测波长257nm.结果:头孢他啶在5ppm~14ppm范围内线性关系良好(r=0.9997),检测限0.0625ppm,定量限0.2ppm,平均回收率99.6%.结论:本法简单,快捷,准确,适合控制冲洗液中头孢他啶的残留量. Objective: A method for determination of rinse water to equipment of packing separately ceftazidime for injection was established. It can control the residual amounts of ceftazidime in rinse water. Methods: UV Speclrophotometry; detector wavelength :257nm. Results: The linearity is good for ceftazidime within the range of 5ppm~14ppm (r=0.9997), limit of detection is 0.0625ppm, limit of quantitation is 0.2ppm, the average recovery rale is 99. 6%. Conclusion: The method is simple, rapid and accurate. It is suitable for controling the residual amounts of ceftazidime in rinse water.
作者 叶夏 詹小如
出处 《黑龙江医药》 CAS 2007年第5期436-439,共4页 Heilongjiang Medicine journal
关键词 紫外-可见分光光度法 头孢他啶 冲洗液 残留量 UV Spectrophtometry ceftazidime rinse water residual amounts
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参考文献3

  • 1注射用头孢他啶.中国药典2005版二部[S].
  • 2检验方法验证.中国药品生产验证指南(2003年版)[S].
  • 3清洗验证指引.美国FDA[S]

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