HPLC法测定鼻炎康片中马来酸氯苯那敏的含量

Quantitative Determination of Chlorphenamine Maleate in Biyankang Tablets by HPLC

[目的]建立HPLC法测定鼻炎康片中马来酸氯苯那敏的含量。[方法]采用Phenomenex C18 Gemini(250×4.6mm,5u)色谱柱,柱温为室温,以甲醇-庚烷磺酸钠冰醋酸混合溶液(60∶40)用三乙胺调节到pH到3.5为流动相;流速为1.0ml·min-1;检测波长:224nm。[结果]马来酸氯苯那敏进样量在0.253μg～1.265μg范围内与峰面积呈良好线性关系(r=0.9993),平均回收率为99.50%,RSD=1.6%(n=5)。[结论]方法简便,结果准确,可作为本品质量控制的有效方法。

[Objective] To establish an HPLC method for the quantitative determination of Chlorphenamine Maleate in Biyankang Tablets.[Methods]The determination was performed on Phenomenex C18 column with the mobile phase consisted of methanol -mixed solution of sodium heptane sulfonate and glacial acetic acid(60∶40,adjuseted to pH3.5 with triethylaminum) at ambient temperature.The flow rate was 1.0ml·min-1.The detection wavelength was set at 224nm.[Results]The method showed a good linear relationship within the range of Chlorphenamine Maleate 0.509μg～2.545μg (r=0.9993,n=5).The average recovery was 99.50% with RSD=1.6% (n =5).[Conclusion]The method is simple and accurate and could be used for quality control of Biyankang Tablets.