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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 improve the quality of Shunhua Sputum, the content of dissolution of chlorphenamine maleate in Shunqi Sputum is determined by high performance liquid chromatography (HPLC). Methods The dissolution rate was measured at 100 r / min with 100 ml of 0.1 mol / L HC1 solution and 45 min of sampling. The chromatographic separation was performed on a Waters C 18 column (3.0 mm × 100 mm, 3.5 μm) The mobile phase was pH 3.0 with methanol-0.05 mol / L sodium dihydrogen phosphate (40:60) 10% phosphoric acid. The flow rate was 0.3 ml / min and the wavelength was 264 nm. Results The average recoveries of chlorpheniramine maleate in Shunhua Sputum Tablets were 99.74%, the relative standard deviation (RSD) was 0.7%, the linear range of chlorpheniramine maleate was 0.75 ~ 60μg / ml (r = 0.9997). Conclusion HPLC method is simple, sensitive and accurate, and it is suitable for the determination of Dissolution of chlorphenamine maleate in Shunqi Sputum.