复方氨酚烷胺胶囊中3种主要成分的测定及溶出度比较

Determination and Dissolution Comparison of Three Elements in Compound Paracetamot and Amantadine Lydrochloide Capsules

关键词:  复方氨酚烷胺胶囊  高效液相色谱法  溶出度  相似因子  对乙酰氨基酚  马来酸氯苯那敏  咖啡因

Key words:  compound paracetamol and amantadine hydrochloride capsules  HPLC  dissolution rate  similarity factor  paracetamol  chlorphenamine maleate  caffeine

摘要:

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，5 μm)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2.50~250.10，0.20~19.50，0.61~60.74 μg·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。

Abstract:

OBJECTIVE To establish an HPLC method for simultaneous determination of three components (paracetamol, chlorphenamine maleate and caffeine) of compound paracetamol and amantadine hydrochloride capsules, and applied this method to investigate the above three components’ differences of dissolution rate in vitro. METHODS Using Alltima C₁₈ (4.6 mm×150 mm, 5 μm) chromatographic column, mobile phase was methanol-KH₂PO₄ (0.05 mol·L^-1, pH 3.0)-triethylamine (20∶80∶0.02) and flow rate was 1 mL·min^-1, detected at 216 nm. The dissolution rate was measured by rotating basket method, applied 1 000 mL water as dissloution medium[80 r·min^-1, (37±0.5)℃], calculated cumulative dissolution percentage of each component at different time, then used similarity factor to compare the similarity of dissolution curve. RESULTS The linearity range of paracetamol, chlorphenamine maleate and caffeine were 2.50-250.10, 0.20-19.50 and 0.61-60.74 μg·mL^-1, and their correlation coefficient (r) were 1.000, 1.000, and 0.999 9, compared with paracetamol, chlorpheniramine maleate and caffeine’s similarity factors were 34 and 73. CONCLUSION The HPLC method is simple, accurate and reproducible and can be used to control the quality of the preparation, the determination of dissolution results show that the above three components don’t all have characteristics of synchronous dissolution.