HPLC法测定小儿四维葡钙片和颗粒中三种水溶性维生素的含量

目的：建立HPLC测定小儿四维葡钙片和颗粒中维生素C、维生素B1、维生素B2含量的方法.方法：采用AlltimaTMC18（250 mm×4.6 mm,5μm）色谱柱,流动相：0.03 mol·L-1磷酸氢二铵溶液（加入0.05％庚烷磺酸钠,用磷酸调节pH至3.0）-甲醇,梯度洗脱,进样量：20 μl,检测波长：265 nm,流速：1.0 ml·min-1,柱温30℃.结果：维生素C、维生素B1、维生素B2分别在0.530～6.356 μg（r=1.000 0）、0.043 0 ～0.516 4 μg（r=1.000 0）、0.019 4 ～0.232 8 μg（r=1.000 0）范围内线性关系良好,片剂的平均回收率分别为99.79％（RSD =0.15％,n=9）、99.43％（RSD=0.45％,n=9）、99.14％（RSD =0.49％,n=9）;颗粒剂的平均回收率分别为为99.56％（RSD =0.14％,n=9）、99.14％（RSD=0.45％,n=9）、99.13％（RSD=0.42％,n=9）.结论：本法简便、准确、可靠,可用于小儿四维葡钙片和颗粒中维生素C、维生素B1、维生素B2的质量控制.

Determination of Three Water soluble Vitamins in Pediatric Four Vitamins and Calcium Gluconate Tablets and Granules by HPLC

Objective：To establish a content determination method for vitamin C,vitamin B1 and vitamin B2 in pediatric four vitamins and calcium gluconate tablets and granules.Methods：The determination was performed on an AlltimaTM C18 （250 mm× 4.6 mm,5 μm） column at 30℃ with the detection wavelength of 265nm.The mobile phase was composed of 0.03 mol · L-1 ammonium phosphate solution （0.05％ sodium heptanesulfonate was added and the pH value was adjusted to 3.0 with phosphoric acid） and methanol with gradient elution.The flow rate was 1.0 ml · min-1 and the injection volume was 20μl.Results：Vitamin C,vitamin B1 and vitamin B2 was in good linearity within the range of 0.530-6.356 μg （r =1.000 0）,0.430-0.516 4 μg （r =1.000 0） and 0.019 4-0.232 8 μg（r =1.000 0）,respectively.The mean recovery of the tablets was 99.79％,99.43％ and 99.14％ with RSD of 0.15％,0.45％ and 0.49％ （n =9）,respectively,and the mean recovery of the granules was 99.56％,99.14％ and 99.13％ with RSD of 0.14％,0.45％ and 0.42％ （n =9）,respectively.Conclusion：The method is simple,accurate and reliable,and suitable for the quality control of vitamin C,vitamin B1 and vitamin B2 in pediatric four vitamins and calcium gluconate tablets and granules.