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目的:建立一种快速检测头孢地嗪钠清洁残留的方法,有效地控制产品的交叉污染。方法:采用DIONEX summit液相色谱系统,Agilent Eclipse XDB-C18(150mm×4.6mm,5μm)色谱柱;流动相:磷酸盐缓冲液(取磷酸二氢钾0.87g与无水磷酸氢二钠0.22g,加水溶解并稀释至1000mL,摇匀)-乙腈(920∶80);流速:1mL.min-1;紫外检测波长:262nm。棉签擦拭取样。结果:头孢地嗪的浓度在4.18～52.28μg·mL-1范围内线性关系良好(r=0.9998),检测限和定量限分别为0.11ng和0.32ng,取样回收率平均为83.3%。结论:用HPLC法测定头孢地嗪的残留灵敏度高,是一种快速可靠的质量控制手段。
OBJECTIVE: To establish a rapid method for the determination of cefodizime sodium for cleaning residue and to effectively control the cross-contamination of the product. METHODS: The mobile phase consisted of DIONEX summit system and Agilent Eclipse XDB-C18 (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of phosphate buffer (0.87 g monobasic potassium phosphate and 0.22 g anhydrous sodium phosphate dibasic , Dissolved in water and diluted to 1000mL, shake) - acetonitrile (920:80); flow rate: 1mL.min-1; UV detection wavelength: 262nm. Cotton swab sampling. Results: The linear range of cefodizime was 4.18 ~ 52.28μg · mL-1 (r = 0.9998). The limit of detection and limit of quantification were 0.11ng and 0.32ng, respectively. The average recoveries of cefodizime were 83.3%. Conclusion: It is a fast and reliable quality control method to determine the residual sensitivity of cefodizime by HPLC.