Determination of Process Impurities and Degradation Products in Faropenem Sodium by HPLC
An ion-pair reversed phase high performance liquid chromatography method was established for the determination of the process impurities and degradation products in faropenem sodium(1).The Welch Xtimate C18 column(4.6 mm× 150 mm,3 μm)was used,and the analysis was carried out in the gradient elution mode with phosphate buffer(pH 3.0)as mobile phase A,and phosphate buffer-acetonitrile(50∶50)as mobile phase B.The flow rate was 1.0 mL/min,the column temperature was 25 ℃,and the injection volume was 20 μL.The results showed that the peaks of 1 and its related impurities were separated well,and it was linear for 1 and the related impurities in the corresponding ranges.The average recoveries(n=9)of the impurities were 96.35％-104.28％,with the RSDs of 1.38％-4.25％.The established method has high accuracy,sensitivity,specificity,and repeatability,which is suitable for the determination of process impurities and degradation products in 1.
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