HPLC测定维生素B12注射液的含量和有关物质

 目的 建立测定维生素B₁₂的含量和有关物质的高效液相色谱法。 方法 采用以十八烷基硅烷化学键合硅胶为填充剂的色谱柱，流动相为甲醇-磷酸盐缓冲液pH 3.5(26∶74)，检测波长为361 nm。 结果 线性浓度范围20.22～505.60 mg·L-1(r=0.999 97)，最低检测限为3 ng，样品溶液(避光保存)至少在24 h内稳定，平均回收率为100.8%，精密度(RSD=0.1%)、重复性(RSD=0.1%)良好。结论 用同一高效液相色谱法来测定含量和有关物质，经方法学验证，此方法简便、灵敏、准确。

Determination of Content and Related Substances in Vitamine B_(12) Injection by HPLC Method

OBJECTIVE To establish a high performance liquid chromatography assay for the determination of vitamine B₁₂injection. METHODS C₁₈ was packed in the analytical column. The mobile phase consisted of methanol-phosphate buffer solvent pH 3.5 (26∶74). The detection wavelength was 361 nm. RESULTS The calibration curve was linear in the range of 20.22 to 505.60 mg·L-1(r=0.999 97). The LOD was 3 ng. The sample solution kept in dark place was stable within 24 h. The average recoveries were 100.8%. Validation(RSD= 0.1%) and repeatability (RSD=0.1%) were good. CONCLUSION This method was simple, sensitive and could be used for the quality evaluation of vitamine B₁₂ injection.