目的 建立測定注射用頭孢唑肟鈉中有關(guān)物質(zhì)的HPLC法。方法 采用Agient Eclipse C₁₈色譜柱（250 mm×4.6 mm，5 μm）；以乙腈–pH 3.6緩沖液（取枸櫞酸1.42 g、磷酸氫二鈉2.31 g，加水溶解并稀釋至1 000 mL）為流動相，進行梯度洗脫；檢測波長：254 nm；柱溫：40℃；體積流量：0.8 mL/min；進樣量20 μL。結(jié)果 頭孢唑肟在0.24～14.52 μg/mL與峰面積呈良好的線性關(guān)系（r=1.000 0），最低檢出質(zhì)量濃度0.03 μg/mL。結(jié)論 采用的HPLC方法簡單、專屬性強，可有效控制注射用頭孢唑肟鈉產(chǎn)品的質(zhì)量。

Objective To establish a method for the determination of related substances in Ceftizoxime Sodium for injection by HPLC. Methods The determination was carried out on Agient Eclipse C₁₈ column (250 mm × 4.6mm, 5 μm) with the mobile phase containing acetonitrile-buffer solution (pH 3.6) (dissolve citric acid monohydrate 1.42 g and disodium hydrogen phosphate dodecahydrate 2.31 g in water and diluted to 1 000 mL) with gradient elution. The detective wavelength was set at 254 nm. The temperature of column was set 40℃. The flow rate was 0.8 mL/min with injection volume of 20 μL. Results The linearity range of ceftizoxime sodium was 0.24-14.52 μg/mL (r=1.000 0), and LOD was 0.03 μg/mL. Conclusion The method is simple and selective to be used for the quality control of Ceftizoxime Sodium for injection products effectively.