袁训贤，朱美临 (默克雅柏药业[中国]有限公司  广东中山528437)

摘 要  目的：建立一种高效液相色谱法可快速测定双扑伪麻口服溶液中3组分及对氨基酚。方法：使用C18色谱柱；采用梯度洗脱：取2.02g戊烷磺酸钠，溶于0.2%的三乙胺溶液1000ml，用磷酸调pH值至3.0，经0.45um滤过，为流动相A；乙腈为流动相B，按梯度洗脱，流速约为1ml/min；检测波长：218nm。结果：对乙酰氨基酚在1.1-2.1mg/ml浓度范围内r=0.9992,RSD1.0,；盐酸伪麻黄碱在0.1-0.2mg/ml浓度范围内r＝0.9996，RSD0.6；马来酸氯苯那敏在7-13µg/ml浓度范围内r＝0.9996，RSD1.1；对氨基酚在1.6-14.4µg/ml浓度范围内r＝0.9993，RSD1.2。结论：本方法可行，能快速而准确地检测双扑伪麻口服溶液中3组分及对氨基酚，操作简便，结果准确。

    关键词  双扑伪麻口服溶液  质量控制  对氨基酚

Simultaneous Determination of Three Components in Shangpuweima Oral Solution by HPLC

Yuan Xunxian, Zhu Meilin (Merck Apotec Pharmaceutical (China) Co.Ltd, Zhongshan, Guangdong, 528437, P. R. China)

ABSTRACT Objective: To develop a HPLC method for determination three components in Shangpuweima oral solution. Method: The Diamonsil C₁₈ column (4.6×250mm, 5μm) was used. The mobile phase A (dissolve sodium pentanesulphonate 2.02g in 1000ml of 0.2% Triehtylamine), adjust pH to 3.0 with phosphoric acid. The mobile phase B was acetonitrile. The flow rate was 1ml·min^-1. The detection wavelength was 218nm, using linear gradient elution method. Result: The calibration curves were linear in ranges of 1140-2070 mg·ml^-1 for paracetamol, 110-190μg·ml^-1 for pseudoephedrine hydrochloride, 7.05-12.94µg·ml^-1 for chlorphenamine maleate. The average recoveries were 100.2 %( RSD=0.5%), 100.6% (RSD=0.5%) and 101.0 %( RSD=0.7%), respectively. Conclusion: The method is simple, fast for simultaneous determination of three components in Shangpuweima oral solution.

KEY WORDS Shangpuweima oral solution; Quality control; 4-aminophenol