HPLC_法测定维生素B₂_注射液的含量及有关物质

目的: 建立高效液相色谱法测定维生素B₂注射液的含量和有关物质。 方法: 采用C₁₈ 色谱柱(250 mm×4.0 mm,5 μm);以10 mmol·L^-1 庚烷磺酸钠的0.5%醋酸溶液-乙腈-甲醇(85∶ 10∶ 5)为流动相;流速:1.0 mL·min^-1 ;检测波长:444 nm。 结果: 在建立的色谱条件下,维生素B₂与杂质能完全分离;维生素B₂浓度在5.148~64.352 μg·mL^-1 范围内线性关系良好,r=1.000;平均回收率为100.2% (n=9);测定维生素B₂的最小检出量为2.2 ng。 结论: 本方法简便、准确,灵敏度高,专属性强,可用于维生素B₂注射液的质量控制。

Objective: To establish a method for the determination of content and related substances for vitamin B₂ injection. Methods: C₁₈ column (4.0 mm×250 mm,5 μm) was adopted with the mobile phase of a mixture of 10 mmol·L^-1 sodium heptanesulfonate solution(0.5% acetic acid)-acetonitrile-methanol (85∶ 10∶ 5).The flow rate was 1.0 mL·min^-1 and the detection wavelength was set at 444 nm. Results: Under the described chromatographic condition,vitamin B₂ was completely separated from its impurities.A linearity between peak area and vitamin B₂ concentration was achieved in the range of 5.148-64.352 μg·mL^-1,with r of 1.000.The average recovery(n=9) was 100.2%.The lowest detectable amount was 2.2 ng. Conclusion: The method is convenient accurate,specific and sensitive and can be used for quality control of vitamin B₂ injection.