高效液相色谱法测定复方锌布颗粒剂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 Compound Zinc Gluconate and Ibuprofen Granules by HPLC

目的建立测定复方锌布颗粒剂中马来酸氯苯那敏含量及含量均匀度的高效液相色谱(HPLC)法。方法色谱柱采用Capcell PAK C_(18)柱(250 mm×4.6 mm,5μm),流动相为0.05 mol/L KH2PO4(含0.1%三乙胺,以磷酸调节p H至2.5)-乙腈(80∶20),流速为1.0 m L/min,柱温为35℃,检测波长为263 nm。结果马来酸氯苯那敏质量浓度在0.006 356~0.203 4 g/L(r=1.000 0)范围内与峰面积线性关系良好,平均回收率为100.17%,RSD为0.97%(n=9)。结论该方法简便、快捷,可有效、准确地测定马来酸氯苯那敏的含量及含量均匀度,可用于复方锌布颗粒剂的质量控制。

Objective To establish an HPLC method for the determination of content and content uniformity of chlorphenamine maleate in Compound Zinc Gluconate and Ibuprofen Granules.Methods The Capcell PAK C18 column（250 mm × 4.6 mm,5 μm） was adopted,the mobile phase was 0.05 mol/L KH2PO4（containing 0.1% triethylamine three,p H was adjusted to 2.5 by phosphoric acid）-acetonitrile（80 ∶ 20）,the flow rate was 1.0 m L/min,the column temperature was 35 ℃,the wavelength was 263 nm.Results There was a good linear relationship within the range of 0.006 356-0.203 4 g/L（r = 1.000 0）.The average recovery was 100.17%,RSD was0.97%（n = 9）.Conclusion The method is convenient,rapid,effective and accurate for the determination of content and content uniformity of chlorphenamine maleate,which can be used in the quality control of Compound Zinc Gluconate and Ibuprofen Granules.