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HPLC法测定注射用核黄素磷酸钠的含量
  • 时间:0
  • 分类:R927.2[医药卫生—药学]
  • 作者机构:[1]河南省食品药品检验所,河南郑州450000, [2]三门峡市公安局,河南三门峡472000, [3]河南科技大学医学技术与工程学院,河南洛阳471003
  • 相关基金:国家自然科学基金资助项目(No.81071230)
中文摘要:

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。

英文摘要:

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.

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