奥美拉唑碳酸氢钠干混悬剂溶出度方法学研究

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中文摘要：目的:考察奥美拉唑碳酸氢钠干混悬剂溶出度方法学,对比自研样品与参比制剂在溶出介质中的溶出行为.方法:桨法,HPLC法,溶出介质是pH=7.4的磷酸盐缓冲液.结果:在0.7596～18.230 0 μg/mL范围内线性良好,精密度6 次进样的RSD<2.0%,平均回收率为 99.31%,RSD为0.71%.结论:该溶出度方法系统适用性良好,准确度高,适合奥美拉唑碳酸氢钠干混悬剂溶出度的测定.

外文标题：Study on the Dissolution Method of Omeprazole Sodium Bicarbonate Dry Suspension

外文摘要：Objective:To investigate the dissolution methodology of omeprazole sodium bicarbonate dry suspension and compare the dissolution behavior of self-developed samples and reference formulations in the dissolution medium.Method:Paddle method,HPLC method,dissolution medium is phosphate buffer solution with pH 7.4.Result:The linearity was good within the range of 0.759 6～18.230 0 μg/mL,with a precision of less than 2.0%for 6 injections,an average recovery rate of 99.31%,and an RSD of 0.71%.Conclusion:This dissolution method has good applicability and high accuracy,and is suitable for determining the dissolution of omeprazole sodium bicarbonate dry suspension.

外文关键词：

omeprazole sodium bicarbonate dry suspensionpaddle methodphosphate buffer solution

作者：

潘丽、汤宽霞

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作者单位：

海口市制药厂有限公司,海南海口 570311

关键词：

奥美拉唑碳酸氢钠干混悬剂桨法磷酸盐缓冲液

出版年：

2024

DOI：