顺气化痰片中马来酸氯苯那敏的溶出度分析

HPLC determination of the dissolution of chlorphenamine maleate in Shunqi Huatan tablets

目的为提高顺气化痰片质量,对顺气化痰片中马来酸氯苯那敏的溶出度含量采用高效液相色谱法(HPLC)进行测定。方法以0.1 mol/L HC1 100 ml为溶剂,转速为100 r/min,进行了溶出度测定法操作,45分钟取样,采用Waters C_(18)色谱柱(3.0 mm×100 mm,3.5μm),以甲醇-0.05 mol/L磷酸二氢钠(40:60)\10%磷酸调节p H为3.0为流动相,0.3 ml/min的流速,波长264 nm。结果顺气化痰片中马来酸氯苯那敏的平均回收率为99.74%,相对标准偏差(RSD)=0.7%,马来酸氯苯那敏的线性范围为0.75~60μg/ml(r=0.9997)。结论 HPLC法简便、灵敏、准确,适用于顺气化痰片马来酸氯苯那敏的溶出度测定。

Objective To establish an HPLC method for determination of chlorphenarnine maleate in Shunqi Huatan tablets.Granules.Methods The dissolution rate was determined by HPLC,with 0.1 mol/L hydrochloric acid as dissolution medium and rotation speed at 1 00 r/min.The samples were separated by an Waters C18 column（100×3.0 mm 3.5μm）with methanol-0.05 mol/L Nail2 PO4（40：60）,（adjusted pH to 3 with H2PO4）as nobile phase and detected at 264 nm for chlorphenamine maleate with a flow rate of 0.3ml/min.Resuits The method had good linear relationship in the ranges of 0.75--60 μg/ml for chlorphenamine maleate（r=0.9997）.The average recovery of chlorphenamine maleate was 99.74%（RSD=0.7%）in tablets.Conclusion The HPLC method is simple,sensitive and accurate, suitable for shunqihuatan tablets of Chlorphenamine Maleate dissolution.