目的 建立HPLC法檢測頭孢克肟分散片中有關(guān)物質(zhì)。方法 采用Inertsil ODS-3色譜柱（250 mm×4.6 mm，5μm）；流動相：四丁基氫氧化銨溶液–乙腈（75：25）；檢測波長：254 nm；柱溫：40℃；體積流量：調(diào)整流速使頭孢克肟主峰保留時間在15～20 min；進(jìn)樣體積：20 μL。結(jié)果 該法專屬性良好，干擾性符合相關(guān)要求，頭孢克肟與相鄰雜質(zhì)以及各已知雜質(zhì)之間的分離均良好；頭孢克肟和各已知雜質(zhì)的質(zhì)量濃度與峰面積之間線性關(guān)系均良好（r>0.999 5）；精密度、準(zhǔn)確度和耐用性均良好；頭孢克肟分散片6批自制品與3批參比制劑的雜質(zhì)譜基本一致，各批樣品均符合制訂質(zhì)量標(biāo)準(zhǔn)的規(guī)定。結(jié)論 所建立的方法可用于簡便、快速、準(zhǔn)確地檢測頭孢克肟分散片中有關(guān)物質(zhì)。

Objective To establish a method for the determination of related substances in Cefixime Dispersible Tablets by HPLC. Methods The chromatographic separation of the related substances was performed on an Inertsil ODS-3 column (250 mm×4.6 mm, 5 μm) with tetrabutylammonium hydroxide solution- acetonitrile (75:25) as mobile phase. The detection wavelength was 254 nm. The column temperature was 40℃. Volume flow rate adjusted the flow rate so that the retention time of the main peak of cefixime was 15-20 min with injection volume of 20 μL. Results The established method had good specificity, satisfactory interference, and there was a good separation between cefixime and adjacent impurity and known impurity. The linear relationship between concentration and corresponding peak area of cefixime and all related substances were ideal (r > 0.999 5). The precision, accuracy, and durability of this method were fine. The impurity spectra of 6 batches of self-made preparations and 3 batches of reference preparations of cefixime dispersible tablets were basically consistent, complying with the established quality standards. Conclusion The established method is simple, prompt, and accurate, which can be used to determine the related substances in Cefixime Dispersible Tablets.

R914