高效液相色谱法测定酚麻美敏口腔崩解片中对乙酰氨基酚、氢溴酸右美沙芬、盐酸伪麻黄碱和马来酸氯苯那敏4组分的含量

 目的建立高效液相色谱法测定酚麻美敏口腔崩解片中对乙酰氨基酚、氢溴酸右美沙芬、盐酸伪麻黄碱和马来酸氯苯那敏4组分的含量。方法采用两个条件下测定上述4种成分,测定对乙酰氨基酚时,采用LiChroCART(4.6 mm×150 mm,5μm)色谱柱;甲醇-0.75%醋酸溶液(25∶75)为流动相;检测波长为280 nm。测定氢溴酸右美沙芬、盐酸伪麻黄碱和马来酸氯苯那敏时,采用Luna SCX 100A(4.6 mm×250 mm,5μm)色谱柱;乙腈-0.05 mol·L^-1磷酸二氢钾溶液(68∶32)为流动相;检测波长为265 nm。结果质量浓度依次为对乙酰氨基酚10.0～100.0 mg·L^-1、氢溴酸右美沙芬5.161～25.80 mg·L^-1、马来酸氯苯那敏0.978～4.890 mg·L^-1、盐酸伪麻黄碱14.93～74.64 mg·L^-1内与各自的峰面积呈良好的线性关系,r分别为1.000 0,1.000 0,0.998 8,1.000 0。平均回收率依次为对乙酰氨基酚99.7%,RSD为1.53%;氢溴酸右美沙芬100.4%,RSD为1.09%;马来酸氯苯那敏99.2%,RSD为1.93%;盐酸伪麻黄碱97.6%,RSD为1.21%。结论本方法精密度好,结果准确可靠,适用于该复方制剂的质量控制。

Determination of Four Ingredients of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorphenamine Maleate in Oral Disintegrating Tablets by HPLC

OBJECTIVE To establish a method for the determination of the four contents of paracetamol,pseudoephedrine hydrochloride,dextromethorphan hydrobromide,and chlorphenamine maleate in oral disintegrating tablets by HPLC.METHODS The samples were separated on a LiChroCART column(4.6 mm×150 mm,5 μm) was used.The mobile phase consisted of methanol0.75% acetic acid(25∶75) and the ultraviolet wavelength was at 280 nm for paracetamol.On the other hand,the separation was performed on a Luna SCX 100A column(4.6 mm×250 mm,5 μm) with a mobile phase of acetonitrile-0.05 mol·L^-1 potassium dihydrogen phosphate(68∶32) for the determination of dextromethorphan hydrobromide,pseudoephedrine hydrochloride and chlorphenamine maleate, the detect wavelength was 265 nm.RESULTS The calibration curves were linear in the range of 10.0～100.0 mg·L^-1 for paracetamol(r=1.000 0),5.161～25.80 mg·L^-1 for dextromethorphan hydrobromide(r=1.000 0),0.978～4.890 mg·L^-1 for chlorphenamine maleate(r=0.998 8),14.93～74.64 mg·L^-1 for pseudoephedrine hydrochloride(r=1.000 0).The average recoveries were 99.7% with RSD of 1.53%;100.4% with RSD of 1.09%;99.2% with RSD of 1.93%;97.6% with RSD of 1.21% for four above mentioned components,respectively.CONCLUSION The method is accurate and reliable for the quality control of this compound preparation.