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目的:建立HPLC方法测定维生素B12片的含量及含量均匀度。方法:色谱柱为Agilet Eclipse XDB-C18(250 mm×4.6 mm,5μm),流动相为0.02 mol·L-1磷酸氢二钠溶液-甲醇(74∶26),流速为1.0 ml·min-1,检测波长为225 nm,柱温为30℃,进样量为20μl。结果:维生素B12在1.67~41.72μg·ml-1浓度范围内与峰面积线性关系良好(r=1.000 0)。平均回收率为99.9%(RSD=0.40%,n=9)。结论:本方法结果准确可靠,重复性好,可作为维生素B12片的含量及含量均匀度测定方法。
Objective: To establish HPLC method for the determination of vitamin B12 tablets content and content uniformity. METHODS: The column was Agilet Eclipse XDB-C18 (250 mm × 4.6 mm, 5 μm) with a mobile phase of 0.02 mol·L -1 disodium hydrogen phosphate solution (74:26) at a flow rate of 1.0 ml · min -1 , The detection wavelength was 225 nm, the column temperature was 30 ℃ and the injection volume was 20μl. Results: Vitamin B12 had a good linear relationship with the peak area in the range of 1.67 ~ 41.72μg · ml-1 (r = 1.000 0). The average recovery was 99.9% (RSD = 0.40%, n = 9). Conclusion: The method is accurate and reliable, with good repeatability. It can be used as a method for determination of vitamin B12 content and content uniformity.