高效液相色谱法测定维生素C注射剂的含量

Determination of vitamin C for injection by HPLC

目的:建立一种灵敏、准确的高效液相色谱(HPLC)测定维生素C注射剂的方法,并进行分析方法学验证。方法:采用色谱柱为Xterra RP C18(4.6×150mm,5μm),柱温为25℃,以0.01mol·L-1(pH为3.5)的磷酸二氢钠为流动相,系统流速为0.6mL·min-1,检测波长为265nm。结果:该方法的线性范围为50～120μg·mL-1,其标准曲线的相关系数为0.9992,日内RSD为0.87%,其日间RSD为1.03%,加样回收率为100.36%。结论:此法灵敏、准确、高效,重复性好,可用于注射用维生素C的含量测定。

Objective： To develop a sensitive and accurate High Performance Liquid Chromatography Assay （HPLC） for the quantitative analysis of vitamin C for injection. Method： HPLC for the determination of vitamin C for injection, was performed, using Waters 600 systems on a Xterra RP C ts （4.6×150mm,5μm） column, with the mobile phase of 0.01 mol.U1 dibasic sodium phosphate buffer solution （pH=3.5）, at the dectective wavelength of 265nm, with the flow rate of 0.6mL·min^-1, column temperature at 25℃. Result： According to the chromatographic conditions, sampling the reference mixture, the linear range was 50- 120μg·mL^-1 and correlation coefficient was 0.9992, RSD% of inter-day and within-day precision was 0.87% and 1.03% respectively, Recovery was 100.36%.