高效液相色谱-二极管阵列检测器法测定复合维生素B片中5种组分的溶出度

Determination of dissolution rate of five components in compound vitamin B tablets by HPLC-DAD

目的建立高效液相色谱-二极管阵列检测器(HPLC-DAD)法同时测定复合维生素B片中的5种有效成分的溶出度。方法采用Waters XBridge C18色谱柱,以5 mmol/L庚烷磺酸钠水溶液(含0.15%三乙胺,用冰醋酸调节pH值至5.0)为流动相A,乙腈为流动相B,流速为1.0 mL/min,梯度洗脱,柱温35℃,维生素B1、维生素B2、维生素B6和烟酰胺的检测波长为280 nm,泛酸钙的检测波长为210 nm。结果维生素B1、维生素B2、烟酰胺、维生素B6和泛酸钙分别在9.46~47.29、7.97~39.83、39.92~199.60、1.21~6.04、3.84~19.22μg/mL范围内线性关系良好,r均大于0.999。5种组分的回收率在94.3%~102.7%之间,RSD≤2.0%。结论 HPLC-DAD法同时测定复合维生素B片中的5种有效成分的溶出度可为复合维生素B片的质量控制提供参考。

Objective To establish a method for simultaneous determination of dissolution rate of five effective components in compound vitamin B tablets by HPLC-DAD.Methods Waters XBridge C18 was used.Mobile phase A is 5 mmol/L sodium heptanesulfonate solution(containing 0.15% Triethylamine,adjusted pH to 5.0 with glacial acetic acid),Mobile phase B is acetonitrile.The flow rate was 1.0 mL/min.Column temperature was 35℃.The UV detection wavelength of vitamin B1,vitamin B2,vitamin B6 and nicotinamide was 280 nm,and the UV detection wavelength of calcium pantothenate was 210 nm.Results The linear ranges of vitamin B1,vitamin B2,nicotinamide,vitamin B6 and calcium pantothenate were 9.46-47.29,7.97-39.83,39.92-199.60,1.21-6.04,and 3.84-19.22 μg/mL,respectively,and r was greater than 0.999.The recovery rates of the five components ranged from 94.3% to 102.7%,and RSD≤2.0%.Conclusion HPLC-DAD method for simultaneous determination of the dissolution rate of five active ingredients in compound vitamin B tablets can provide a reference for the quality control of compound vitamin B tablets.