奧美拉唑碳酸氫鈉干混懸劑有關(guān)物質(zhì)方法學驗證

【摘要】目的：對奧美拉唑碳酸氫鈉干混懸劑有關(guān)物質(zhì)方法進行驗證。方法：HPLC法，紫外檢測器，DAD檢測器，梯度洗脫。結(jié)果：各已知雜質(zhì)與奧美拉唑分離度均大于1.5，空白輔料不干擾各雜質(zhì)的檢測。結(jié)論：該方法各雜質(zhì)的準確度良好，峰純度良好，適合奧美拉唑碳酸氫鈉干混懸劑的測定。

【關(guān)鍵詞】奧美拉唑碳酸氫鈉干混懸劑；有關(guān)物質(zhì)；方法學驗證

【DOI編碼】10.3969/j.issn.1674-4977.2024.04.008

Methodological Validation of Related Substances in Omeprazole Sodium Bicarbonate Dry Suspension

PAN Li， TANG Kuanxia

（Haikou Pharmaceutical Factory Co.， Ltd.， Haikou 570311， China）

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.

Keywords： omeprazole sodium bicarbonate dry suspension； related substances； methodology validation

奧美拉唑碳酸氫鈉干混懸劑廣泛用于醫(yī)治胃潰瘍、食管反流病、十二指腸潰瘍以及有關(guān)的胃灼熱和其他癥狀，并且在糜爛性食管炎醫(yī)治與維持康復上效果明顯。（剩余4837字）