HPLC法测定维生素B_(12)片含量及含量均匀度

Determination of Content and Content Uniformity of Vitamin B_(12) Tablets by HPLC

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 an HPLC method for the determination of content and content uniformity of vitamin B12 tablets.Method： The HPLC method was conducted on a C18 column. The mobile phase was 0. 02 mol·L- 1disodium hydrogen phosphate solution-methanol（ 74∶ 26）. The flow rate was 1. 0 ml·min- 1and the detection wavelength was 225 nm. The column temperature was 30℃and the injection volume was 20 μl. Result： The linearity of vitamin B12 was good within the range of 1. 67-41. 72 μg·ml- 1（ r =1. 000 0）. The average recovery was 99. 9%（ RSD = 0. 40%,n = 9）. Conclusion： The method is accurate,reliable and reproducible,and can be used in the determination of content and content uniformity of vitamin B12 tablets.