品牌与标准化Issue(4):22-24,3.DOI:10.3969/j.issn.1674-4977.2024.04.008
奥美拉唑碳酸氢钠干混悬剂有关物质方法学验证
Methodological Validation of Related Substances in Omeprazole Sodium Bicarbonate Dry Suspension
潘丽 1汤宽霞1
作者信息
- 1. 海口市制药厂有限公司,海南海口 570311
- 折叠
摘要
Abstract
Objective:To verify the substance method of omeprazole sodium bicarbonate dry suspension.Method:HPLC,UV detector,DAD detector,gradient elution.Result:The separation degree between all known impurities and omeprazole was greater than 1.5,blank excipients do not interfere with the detection of various impurities.Conclusion:This method has good accuracy and peak purity for various impurities,and is suitable for the determination of omeprazole sodium bicarbonate dry suspension.关键词
奥美拉唑碳酸氢钠干混悬剂/有关物质/方法学验证Key words
omeprazole sodium bicarbonate dry suspension/related substances/methodology validation引用本文复制引用
潘丽,汤宽霞..奥美拉唑碳酸氢钠干混悬剂有关物质方法学验证[J].品牌与标准化,2024,(4):22-24,3.