反相离子对高效液相色谱法测定维生素B_(12)注射液的含量

Determination of Vitamin B_(12) injection by RP-IP-HPLC

目的:建立维生素B12注射液的含量测定方法。方法:采用Kromasil C18柱,以0.16%庚烷磺酸钠溶液-甲醇(82∶18)(用磷酸调pH值3.0)为流动相,流速为1.0ml/min,检测波长361nm。结果:维生素B12进样量在0.04048～0.6072μg范围内与峰面积呈良好的线性关系,r=0.9999(n=5);平均加样回收率为99.0%(RSD=0.59%,n=6)。结论:该法准确、专属性强、重现性好。

Objective： To establish a method for the determination of Vitamin B12 injection by RP-IP-HPLC.Methods： The determination was performed on a Kromasil C18 column with the mobile phase consisted of 0.16% sodium heptanesul fonate solution-methanol（82∶18）（adjusted to pH 3.0 with phosphoric acid） at ambient temperature.The flow rate was 1.0 ml/min.The detective wavelength was 361 nm.Results： The method showed a good linear relation over the range of 0.040 48-0.607 2 μg （r=0.999 9,n=5）.The average recovery was 99.0% for the three different levels of the added amount of Vitamin B12 with RSD=0.59% （n=6）.Conclusion： This method is feasible,convenient,specific and reproducible.It can be used to determine the content of Vitamin B12 injection.