摘要
目的建立HPLC法测定五维赖氨酸口服溶液中维生素C、维生素B6、烟酰胺的含量方法。方法采用AlltimaTMC18色谱柱,流动相:0.03mol·L-1磷酸氢二铵溶液(加入0.05%庚烷磺酸钠和0.2%三乙胺,用磷酸调节pH至3.0)-甲醇,梯度洗脱,检测波长:277nm,流速:1.0 mL·min-1,柱温:30℃。结果维生素C、维生素B6、烟酰胺分别在2.587-20.670μg(r=0.9999)、0.123-0.980μg(r=1.0000)、1.126-9.007μg(r=1.0000)范围内线性关系良好,平均回收率分别为100.00%(RSD=0.10%)、99.06%(RSD=0.28%)、99.67(RSD=0.31%)(n=9)。结论本法简便、准确、可靠,可用于五维赖氨酸口服溶液中维生素C、维生素B6、烟酰胺的质量控制。
Objective To establish an HPLC method for the analysis of vitamin C, vitamin B6 and nicotinamide in Five Vitamins and Lysine Hydrochloride Oral Solution. Methods The procedure was performed on an AlltimaVMC18 column at 30 ℃, and detected at 277 nm. The mobile phase was composed by a gradient of 0.03 mol .L-1 of diammonium phosphate solution (in which 0.05% of sodium heptanesulfonate and 0.2% of triethylamine were added and the pH was adjusted to 3.0 by phosphoric acid) and methanol, with the flow rate at 1.0 mL. min-1. Results Vitamin C, vitamin B6 and nicotinamide were in good linear at 2. 587-20. 670 g (r = 0. 9999), 0. 123-0. 98 (r = 1. 0000) and 1.126-9.007 〉g (r=l. 0000), respectively. The mean recoveries were 100.00% (RSD=0.10%), 99.06% (RSD=0.28%) and 99.67 (RSD=0.31%) (n=9). Conclusion The method is proved to be simple, accurate and reliable, which is appropriate for the quality control for vitamin C, vitamin B6 and nicotinamide in Five Vitamins and Lysine Hydrochloride Oral Solution.
出处
《中国药事》
CAS
2013年第9期949-952,962,共5页
Chinese Pharmaceutical Affairs