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目的:建立HPLC法测定烟酸维生素B_6注射液中烟酸和维生素B_6含量的方法。方法:采用C_(18)(200 mm×4.6 mm,5μm)色谱柱,以0.04%戊烷磺酸钠溶液(用冰醋酸调节pH为3.0±0.05)-甲醇(90:10)为流动相,检测波长为262nm,流速为1.0ml·min~(-1)。结果:烟酸的线性范围为0.04～1.01μg(r=1.000 0,n=7),平均回收率为100.3%(n=9),RSD为0.4%;维生素B_6的线性范围为0.12～3.03μg(r=1.000 0,n=7),平均回收率为100.2%(n=9),RSD为0.5%。结论:本方法快速、准确,可用于烟酸维生素B_6注射液的质量控制。
Objective: To establish a HPLC method for the determination of niacin and vitamin B_6 in niacin vitamin B_6 injection. Methods: The mobile phase consisted of 0.04% sodium pentane sulfonate solution (adjusted to pH 3.0 ± 0.05 with glacial acetic acid) -methanol (90:10) using C 18 column (200 mm × 4.6 mm, The detection wavelength was 262nm and the flow rate was 1.0ml · min ~ (-1). Results: The linear range of niacin was 0.04-1.01 μg (r = 1.000 0, n = 7) with an average recovery of 100.3% (n = 9) and a RSD of 0.4%. The linear range of vitamin B 6 was 0.12-3.0 μg (r = 1.000 0, n = 7) with an average recovery of 100.2% (n = 9) and a RSD of 0.5%. Conclusion: The method is rapid and accurate and can be used for quality control of niacin vitamin B_6 injection.