高效液相色谱法测定复方罗布麻片Ⅰ中维生素B_6的含量

Determination the Content of Vitamin B_6 in Compound Kendir Lenves Tablets Ⅰ by HPLC

目的:建立高效液相色谱法测定复方罗布麻片Ⅰ中维生素B_6含量的方法。方法:采用Agilent HC-C_(18)色谱柱,乙腈-庚烷磺酸钠溶液[取庚烷磺酸钠2.87 g与磷酸二氢钾2.5 g加水溶解稀释至1000 ml,用磷酸(1→3)调节pH至3.5](15∶85)为流动相,柱温:16℃,检测波长为290 nm,流速1.0 ml·min^(-1)。结果:维生素B_6在3.9～118.3μg·ml^(-1)范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为99.1%,RSD=0.80%(n=6)。结论:本法简便、准确、重复性好,可用于该制剂的质量控制。

Objective： To establish a HPLC method for determination the content of vitamin B6 in compound kendir lenves tablets I . Method： A Agilent HC-CIs （250 mm ×4. 6 mm,5 μm） column was used, the aeetonitrile-sodium heptanesulfonate solution （take 2. 87 g· L^-1 of sodium heptanesulfonate and 2. 5 g· L^-1 of potassium dihydrogen phosphate solmtion adjusted pH to 3.5 with dilute phosphoric acid） （ 15：85 ） as mobile phase. The detection wavelength was 290 nm,the flow rate was 1.0 ml.min -1 Result： The linear range of vitamin B6 was 3.9-118. 3 μg·ml^-1 （ r = 0. 999 9 ）. The average recovery was 99. 1%, RSD = 0. 80% （ n = 6 ）. Conclusion： The metnod is simple, accurate and repeatable,it can be used for quality control of this preparation.