高效液相色谱法测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量及均匀度

Determination of the content and uniformity of dosage units in Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Granules by HPLC

目的：建立小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量及均匀度的检测方法。方法采用高效液相色谱法对小儿氨酚黄那敏颗粒中的马来酸氯苯那敏含量及均匀度进行测定。以 shimpack VP-ODS（150 mm ×4．6 mm，5μm）色谱柱为固定相；甲醇-0．01 mol·L －1辛烷磺酸钠溶液（三乙胺调节 pH 值至3．0，63∶37）为流动相；流速为1 mL·min －1；检测波长为261 nm；进样量为10μL。结果马来酸氯苯那敏在7．928～31．712 mg·L －1的范围与峰面积呈良好线性关系，r ＝0．99992。样品中马来酸氯苯那敏的平均回收率为99．8％（n ＝9，RSD ＝0．83％）。用该文建立的方法对5个批次小儿氨酚黄那敏颗粒中的马来酸氯苯那敏含量及均匀度进行了测定，其含量均为标示量的90．0％～110．0％，均匀度符合规定。结论该方法准确可靠，可作为小儿氨酚黄那敏颗粒中马来酸氯苯那敏含量及均匀度的测定方法。

Objective To develop a method for the chlorphenamine maleate detection in Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Granules.Methods HPLC was adopted for the quantitative and uniformity determination of chlorphena-mine maleate.A shimpack VP-ODS column（150 mm ×4.6 mm,5 μm）was used as the stationary phase,with a mobile phase consis-ting of methanol and 0.01 mol·L -1 sodium octane sulfonate solution （adjusted to pH3.0 with triethylamine,63∶37）.The flow rate was 1 mL·min -1 ,the detection wavelength was 261nm and the injection volume was 10 μL.Results Considerable linear relationship was observed when chlorphenamine maleate ranged from 7.928 to 31.712 mg·L -1 （r =0.999 92）.The average recovery of chlorphena-mine maleate was 99.8%（n =9,RSD =0.83%）.Five batches of Pediatric Paracetamol,Artificial Cow-bezoar and Chlorphenamine Maleate Granules were analyzed under the established method with results ranging from 90.0% to 110.0%.Conclusions The devel-oped method is accurate and reliable,which could be used for the quality control of chlorphenamine maleate in Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules.