奥美拉唑胶囊的制备及质量控制

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目的:分析奥美拉唑胶囊的制备方法及其质量控制方法。方法:制备中加入抗酸剂碳酸氢钠,采用高效液相色谱对其含量进行检测。结果:奥美拉唑的质量浓度在(4-16)ug/mL之内,与峰面积线性关系良好;RSD分别为100.35%和0.56%;3批样品的含量分别为99.8%、99.4%和99.8%。结论:该制备法操作简单、测定精准、回收率精确,有助于对奥美拉唑的质量控制,值得在临床推广。
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