HPLC法测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量及含量均匀度

Determination of Content and Content Uniformity of Chlorphenamine Maleate in Xiao'er Anfen Huang Namin Granules by HPLC

目的:建立用HPLC法测定小儿氨酚黄那敏颗粒的含量及含量均匀度。方法:色谱柱为kromasil C_(18)(4.6 mm×250 mm,5μm),流动相为甲醇-0.05 mol·L^(-1)磷酸二氢钾溶液(含三乙胺0.03%,用磷酸调pH值至3.0)(43:57),检测波长为215 nm,柱温为40℃,按外标法进行计算。结果:马来酸氯苯那敏在3.928～19.6 mg·L^(-1)浓度范围内线性关系良好,r=0.9999,平均回收率为100.34%,RSD=0.57%。结论:该法专属性好,简捷、快速、准确,适用于小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量及含量均匀度的测定。

Objective：To establish an HPLC method for determination of content and content uniformity of Chlorphenamine Maleate in Xiao＇ er Anfen Huang Namin Granules. nethod：A Kromasil C18 column（4. 6 mm ×250 mm,5μm）was used and its temperature was set at 40℃. The mobile phase consisted of methanol-0.05 mol·L^-1 potassium dihydrogen phosphate solution,containing 0. 03% triethylamine and adjusting the pH value to 3. 0 with phosphate, （43： 57）. The detection wavelength was 215nm. Results：There was a good linear in the range of 3.928 - 19.64 mg·L^-1 （r = 0.999 9）. The average recovey was 99.79% , and RSD was 0.62% . Conclusion：A specific, simple, rapid, accurate and suitable method is established for determination of content and content uniformity of Chlorphenamine Maleate in Xiao＇ er Anfen Huang Namin Granules.