Xây dựng phương pháp phân tích định lượng hàm lượng cefuroxime trong bột pha hỗn dịch zinat 125mg bằng phương pháp HPLC

This paper presents the process of developing and validating the HPLC method with PDA detector for the determination of cefuroxime in zinnat suspension 125mg. Under the conditions of reverse phase C18 column, mobile phase consisting of methanol - 0.2M ammonium dihydrogen phosphate solution (3862; v/v respectively), and flow rate 1ml.min-1, the detector wavelength is 278nm. Examination of chromatographic system compatibility showed the resolution coefficient between Cefuroxime Acetyl Diasteroisomer B and Cefuroxime Acetyl Diasteroisomer A in standard solution is higher than or equal to 1.5 (3.734). The resolution factor between Cefuroxime axetil diasteroisomer B and Cefuroxime axetil delta-3 isomer is higher than or equal to 1.5 (2.530). The number of theoretical plates for Cefuroxime axetil diasteroisomer A>3000 (9532.2) with % RSD repeated repeat doses not more than 2.0%. Cefuroxime axetil diastereoisomer B 0.95. Cefuroxime axetil diasteroisomer A 1.05. Specificity Time deviation of sample and sample 0.066%. Repeatability Sample content is in the range of 90% to 115%, with % RSD = 0.11 <2%. The correctness of the method is in the range of 98.97% to 100.51%. In accordance with USP34 standards, the stability of cefuroxime powder, the compatibility of the chromatography system, linearity, specificity, repetition, and the correctness meet the desired level of analysis.