Determination of epirubicin and its impurities in pharmaceutical by hydrophilic interaction chromatography

A novel method for the determination of epirubicin by hydrophilic interaction chromatography (HILIC) using high purity silica column with highly polar organic-aqueous buffer as mobile phase has been developed. The buffer pH and concentration in the mobile phase as well as the flow rate have been optimized. The optimal mobile phase is 90% ( V/V) acetonitrile in 40 mmol/L formate buffer (pH 2.9). The flow rate was 1.0 mL/min. The system suitability has been tested under the optimal chromatographic condition, and the results show that the resolutions between the adjacent components and the asymmetry factors of the solutes meet the pharmacopoeia requirements. The proposed method has good linearity ( r = 0.9971-0.9991) and reproducibility (RSD < 1.0 % for the peak area). It has been proved simple and convenient, and applied in the determination of epirubicin and its impurities in epirubicin raw product with satisfactory results.