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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AlltimaTM C18(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:20μl,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0.530~6.356μg(r=1.000 0)、0.043 0~0.516 4μg(r=1.000 0)、0.019 4~0.232 8μg(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。
Objective: To establish a HPLC method for the determination of vitamin C, vitamin B1 and vitamin B2 in children with four-dimensional calcium tablets and granules. METHODS: AlltimaTM C18 (250 mm × 4.6 mm, 5 μm) column was used. The mobile phase was 0.03 mol·L -1 diammonium phosphate (0.05% sodium heptanesulfonate and pH 3.0 with phosphoric acid) -methanol , Gradient elution, injection volume: 20μl, detection wavelength: 265 nm, flow rate: 1.0 ml · min-1, column temperature 30 ℃. Results: The linear relationships of vitamin C, vitamin B1 and vitamin B2 in the range of 0.530 ~ 6.356μg (r = 1.000 0), 0.043 0 ~ 0.516 4μg (r = 1.000 0) and 0.019 4 ~ 0.232 8μg The average recoveries of the tablets were 99.79% (RSD = 0.15%, n = 9), 99.43% (RSD = 0.45%, n = 9) and 99.14% (RSD = 0.49%, n = 9) The average recoveries of the agents were 99.56% (RSD = 0.14%, n = 9), 99.14% (RSD = 0.45%, n = 9) and 99.13% (RSD = 0.42%, n = 9), respectively. Conclusion: The method is simple, accurate and reliable and can be used for the quality control of Vitamin C, Vitamin B1 and Vitamin B2 in pediatric four-dimensional calcium tablets and granules.