【摘要】：目的:采用反相高效液相色譜法對(duì)部分國(guó)產(chǎn)注射用頭孢他啶和原研注射用頭孢他啶的雜質(zhì)進(jìn)行研究。方法:采用自身對(duì)照法對(duì)雜質(zhì)進(jìn)行定量測(cè)定,并用UPLC-MS初步鑒定雜質(zhì)結(jié)構(gòu)。結(jié)果:原研注射用頭孢他啶檢出3個(gè)主要雜質(zhì),5批國(guó)產(chǎn)注射用頭孢他啶均檢出4個(gè)主要雜質(zhì),其中雜質(zhì)4為國(guó)產(chǎn)樣品特有雜質(zhì)。結(jié)論:原研樣品與國(guó)產(chǎn)注射用頭孢他啶雜質(zhì)譜不同,兩者可能具有不同合成路線。
[Abstract]:Objective: to study the impurity of ceftazidime for injection and ceftazidime for injection by RP-HPLC. Methods: the impurity was quantitatively determined by self-control method and the impurity structure was preliminarily identified by UPLC-MS. Results: three major impurities were detected in ceftazidime for injection, and four major impurities were detected in 5 batches of ceftazidime for injection, among which impurity 4 was unique to domestic samples. Conclusion: the impurity spectrum of ceftazidime for injection is different between the original sample and ceftazidime for injection, and they may have different synthetic routes.
【作者單位】： 湖南省食品藥品檢驗(yàn)研究院;
【分類號(hào)】：R927

【參考文獻(xiàn)】

相關(guān)期刊論文 前1條

1 孫雪奇;王野;劉崢;劉華;羅慧萍;袁軍;胡昌勤;;注射用頭孢他啶雜質(zhì)研究[J];藥物分析雜志;2012年12期

【共引文獻(xiàn)】

相關(guān)期刊論文 前2條

1 孫雪奇;趙璐;羅慧萍;易秋艷;袁軍;王野;胡昌勤;;注射用頭孢他啶的毒性及致敏性研究[J];華西藥學(xué)雜志;2014年05期

2 孫雪奇;張Y鈰，

本文編號(hào)：2405891