高效液相色谱法测定复方三维右旋泛酸钙糖浆中四种维生素的含量

Determination of Four Vitamins in Compound Calcium Dextropantothenate Syrup by High Performance Liquid Chromatography

目的:采用高效液相色谱法测定复方三维右旋泛酸钙糖浆中维生素B1、B2、B6和烟酰胺的含量。方法:采用高效液相色谱法进行测定,外标法计算含量。Thermo BetasilC18色谱柱(4.6mm×250mm,5μm),流动相为乙腈-5 mmol·L^-1十二烷基硫酸钠(含0.05%甲酸)溶液,梯度洗脱,流速为1.0mL·min^-1,检测波长为260nm,柱温为30℃。结果:维生素B1的线性范围为5.76~115.2μg/mL(r=0.9999),平均回收率为97.45%、97.71%、98.42%,RSD为2.54%、2.26%、3.19%;维生素B2的线性范围为1.16~23.20μg/mL(r=0.9999),平均回收率为97.71%、97.73%、98.42%,RSD为2.49%、2.57%、2.89%;维生素B6的线性范围为1.72~34.4μg/mL(r=0.9999),平均回收率为96.69%、97.20%、98.11%,RSD为2.35%、2.39%、3.14%;烟酰胺的线性范围为5.76~115.2μg/mL(r=0.9999),平均回收率为96.21%、96.44%、97.99%,RSD为2.16%、2.67%、3.42%。结论:本文采用高效液相色谱法测定复方三维右旋泛酸钙糖浆中四种维生素的含量,该方法操作简便,结果准确,有效地完善了该制剂的质控标准,保证了质量控制的科学性。

Objective:To determine the contents of four vitamins in compound calcium dextropantothenate syrup by HPLC.Methods:The content was determined by HPLC and calculated by external standard method.The chromatographic column was Thermo Betasil C18(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-5mmol·L^-1 sodium dodecyl sulfate(containing 0.05% formic acid)solution,the flow rate was 1.0mL·min^-1,the detection wavelength was 260nm,and the column temperature was 30 C.Results:The linear range of vitamin B1 was 5.76~115.2μg/mL(r=0.9999).The average recovery was 97.45%,97.71%and 98.42%,and the RSD was 2.54%,2.26%and 3.19%.The linear range of vitamin B2 was 1.16~23.20μg/mL(r=0.9999).The aver-age recovery rate was 97.71%,97.73%and 98.42%,and the RSD was 2.49%,2.57%and 2.89%.The linear range of vitamin B6 was 1.72~34.4μg/mL(r=0.9999).The average recovery rate was 96.69%,97.20%and 98.11%,and the RSD was 2.35%,2.39%and 3.14%.The linear range of niacinamide was 5.76~115.2μg/mL(r=0.9999),with an average recovery rate of 96.21%,96.44% and 97.99% and an RSD of 2.16%,2.67%and 3.42%.Conclusion:High performance liquid chromatography was used to deter-mine the contents of four vitamins in compound calcium dextropanothenate syrup.The method was simple and accurate,which ef-fectively improved the quality control standard of the preparation and made the quality control more scientific.