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奧美拉唑碳酸氫鈉干混懸劑雜質(zhì)分析

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【摘要】目的:對(duì)奧美拉唑碳酸氫鈉干混懸劑產(chǎn)生的雜質(zhì)進(jìn)行分析。方法:LC-MS法,辛烷基鍵合硅膠柱。結(jié)果:經(jīng)LC-MS數(shù)據(jù)分析,奧美拉唑碳酸氫鈉干混懸劑共產(chǎn)生5種雜質(zhì)。結(jié)論:該方法能推斷出樣品中雜質(zhì)的結(jié)構(gòu)和來源。

【關(guān)鍵詞】奧美拉唑碳酸氫鈉;LC-MS;雜質(zhì)分析

【DOI編碼】10.3969/j.issn.1674-4977.2024.04.006

Analysis of Impurities in Sodium Bicarbonate Dry Suspension

PAN Li, ZHONG Kanzhi

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

Abstract: Objective: To analyze the impurities produced by forced degradation of omeprazole sodium bicarbonate dry suspension. Methods: Silica gel column is bonded with octyl by LC-MS method. Results: By LC-MS spectrum analysis, 5 impurities are produced of omeprazole sodium bicarbonate. Conclusion: This method can infer the structure and source of the impurities in the sample.

Keywords: omeprazole sodium bicarbonate; LC-MS; impurity analysis

奧美拉唑是一種取代苯并咪唑類質(zhì)子泵抑制劑,可通過特異性抑制胃壁細(xì)胞質(zhì)子泵,減少胃酸分泌。(剩余2655字)

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