高效液相色谱同时测定多维元素片中的维生素B₁、维生素B₆、维生素C、烟酰胺和泛酸

目的:应用高效液相色谱建立同时测定多维元素片中维生素B₁、维生素B₆、维生素C、烟酰胺和泛酸含量的方法。方法:以0.05%(V/V)磷酸溶液和0.3%(W/V)硫代硫酸钠溶液为提取液,采用Alltima C₁₈色谱柱(250 mm×4.6 mm, 5 μm),以50 mmol·L^-1磷酸二氢铵溶液(磷酸调至pH 3.0)-乙腈(95:5)为流动相,流速0.5 mL·min^-1,维生素B₁、维生素B₆、维生素C、烟酰胺的检测波长为275 nm,泛酸的检测波长为210 nm。结果:在本方法中,5个成分的线性关系良好,线性相关系数(r)均大于0.9999;专属性强,5个成分和药品中其他成分以及强制降解产物之间均有良好的分离度;精密度良好,RSD小于2.0%;回收率良好,3个加样浓度的回收率在99.45%和100.5%之间;稳定性满足实验要求,混合对照品溶液中维生素C在常温下12 h内保持稳定,供试品溶液中维生素C在常温下2 h内保持稳定;方法学比较显示:本方法和美国药典方法测定结果一致。结论:该方法准确、简单、快速,可作为多维元素片中维生素B₁、维生素B₆、维生素C、烟酰胺和泛酸同时测定的方法。

Objective:To establish an HPLC method for the simultaneous determination of vitamin B₁, vitamin B₆, vitamin C, niacinamide and pantothenic acid in vitamins with minerals tablets. Methods:Samples were extracted with a solution containing 0.05%(V/V) phosphoric acid and 0.3%(W/V) sodium thiosulfate. An Alltima C₁₈ column(250 mm×4.6 mm, 5 μm) was used for the separation with 50 mmol·L^-1 ammonium dihydrogen phosphate(adjusted pH to 3.0 with H₃PO₄) and acetonitrile(95:5) as the mobile phase at the flow rate of 0.5 mL·min^-1. The detection wavelength was 275 nm for vitamin B₁, vitamin B₆, vitamin C, niacinamide, and 210 nm for pantothenic acid. Results:The method showed good linearity for vitamin B₁, vitamin B₆, vitamin C, niacinamide and pantothenic acid with all correlation coefficients(r) greater than 0.9999; the specificity study showed satisfactory resolutions between vitamin B₁, B₆, C, niacinamide, pantothenic acid, other ingredients and forced degradation products; the precisions were satisfactory with all RSDs less than 2.0%; the spike recoveries of three different concentrations ranged from 99.45% to 100.5% for all compounds; the stability at ambient temperature met the experimental requirements with a 12 h stabilization for vitamin C in combined standard solutions and 2 h stabilization in analytical solutions. Method comparison indicated coincident results between this method and the USP method. Conclusions:This method is accurate, fast and simple, which can be used for the simultaneous determination of vitamin B₁, vitamin B₆,vitamin C, niacinamide and pantothenic acid in vitamins with minerals tablets.