目的建立HPLC测定注射用核黄素磷酸钠中核黄素磷酸钠的方法。方法采用DikmaDiamonsil C18色谱柱(250mm×4.6mm,5μm);流动相为乙腈-0.025mol/L磷酸二氢钾溶液(20:80);流速:1.0mL/min;柱温:25℃;检测波长:267nm。结果此方法在4.01—100μg/mL范围内线性关系良好(r=0.9999),最小检出量为2ng;平均加样回收率99.86%,RSD=0.19%。结论本法快速、准确、专属性和重现性好,可用于注射用核黄素磷酸钠的质量控制。
Objective To establish a HPLC method for determination of riboflavin sodium phosphate for injection. Methods HPLC was used to determine directly riboflavin sodium phosphate for injection on C18 column with the mobile phase of CH3 CN-0. 025 mol/L potassium dihydrogen phosphate solution (20: 80) at a flow rate of 1.0 mL/min and column temperature was 25℃. The detection wavelength was set at 267 nm. Results The calibration curve was linear in range of 4. 01 - 100 μg/mL (r = 0. 9999). The limit of detection for the assay was 2 ng. The average recovery of the added sample was 99.86% and RSD was 0. 19%. Conclusion The method is quick, accurate, and has strong specificity and good reproducibility. It provides a good way for the quality control of riboflavin sodium phosphate for injection.