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目的:建立改进的同时测定氨酚伪麻那敏片(Ⅱ)中对乙酰氨基酚、盐酸伪麻黄碱、马来酸氯苯那敏含量的HPLC法。方法:采用Inertsil C_(18)柱(150 mm×4.6 mm,5μm),流动相:0.3%十二烷基硫酸钠溶液(含0.2%磷酸溶液)-乙腈(45:55)(用浓氨溶液调节pH至3.9),流速为1.0 ml·min~(-1),检测波长215 nm。结果:对乙酰氨基酚、盐酸伪麻黄碱、马来酸氯苯那敏分别在62～682,6.23～68.56,0.384～4.226μg·ml~(-1)浓度范围内与各自峰面积积分值呈良好的线性关系;平均回收率分别为99.47%(RSD=0.24%),99.33%(RSD=0.34%),99.18%(RSD=0.20%)(n=6)。结论:该方法准确、简便,可用于氨酚伪麻那敏片(Ⅱ)中3个组分的含量测定
Objective: To establish an improved simultaneous HPLC method for the determination of paracetamol, pseudoephedrine hydrochloride and chlorphenamine maleate in paracetamol and pseudoephemnamine tablets (Ⅱ). METHODS: Inertsil C 18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 0.3% sodium dodecyl sulfate solution (containing 0.2% phosphoric acid) and acetonitrile (45:55) The pH was adjusted to 3.9, the flow rate was 1.0 ml · min ~ (-1) and the detection wavelength was 215 nm. Results: The values of paracetamol, pseudoephedrine hydrochloride and chlorpheniramine maleate with their respective peak area integral values in the range of 62 ~ 682,6.23 ~ 68.56,0.384 ~ 4.226μg · ml ~ (-1) The average recovery was 99.47% (RSD = 0.24%), 99.33% (RSD = 0.34%) and 99.18% (RSD = 0.20%) (n = 6), respectively. Conclusion: The method is accurate and simple and can be used to determine the content of three components in paracetamol and pseudoephemilol (Ⅱ)