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目的建立同时测定复方氨酚烷胺胶囊中对乙酰氨基酚、马来酸氯苯那敏、咖啡因3个组分含量的方法,并应用此方法考察上述3组分的体外溶出差异。方法采用Alltima C18(4.6 mm×150 mm,5μm)色谱柱,流动相:甲醇-0.05 moL.L-1 KH2PO4(用磷酸调节pH至3.0)-三乙胺(20∶80∶0.02),流速:1 mL·min-1,检测波长:216 nm。溶出度采用转篮法,以水1 000 mL为溶出介质,转速80 r·min-1,温度(37±0.5)℃,分别在不同时间取样计算各成分的累积溶出百分率,采用相似因子进行溶出曲线的相似性比较。结果对乙酰氨基酚、马来酸氯苯那敏、咖啡因的线性范围分别为2.50~250.10,0.20~19.50,0.61~60.74μg.mL-1,r分别为1.000,1.000,0.999 9。马来酸氯苯那敏、咖啡因与对乙酰氨基酚的相似因子分别为34,73。结论该方法简便、准确、重复性好,可用于控制该制剂的质量,溶出度测定实验的结果表明该胶囊中上述3个组分不完全具有同步溶出的特点。
OBJECTIVE To establish a method for simultaneous determination of paracetamol, chlorpheniramine maleate and caffeine in compound paracetamol capsules and to investigate the in vitro dissolution of the above three components by this method. Methods Alltima C18 (4.6 mm × 150 mm, 5 μm) column was used. The mobile phase was methanol-0.05 mol L · L-1 KH2PO4 (adjusted to pH3.0 with phosphoric acid) -triethylamine (20:80:02) 1 mL · min-1, detection wavelength: 216 nm. Dissolution rate was determined by spin basket method with 1 000 mL of water as dissolution medium, rotation speed of 80 r · min-1 and temperature of (37 ± 0.5) ℃. Samples were taken at different times to calculate the cumulative dissolution percentage of each component. Comparison of the similarity of curves. Results The linear ranges of paracetamol, chlorpheniramine maleate and caffeine were 2.50 ~ 250.10, 0.20 ~ 19.50 and 0.61 ~ 60.74μg.mL-1, respectively, and r were 1.000, 1.000 and 0.9999, respectively. Chlorphenamine maleate, similar factors caffeine and acetaminophen were 34,73. Conclusion The method is simple, accurate and reproducible. It can be used to control the quality of the preparation. The results of the dissolution test indicate that the three components in the capsule do not completely dissolve simultaneously.