摘要
目的:建立氨咖黄敏胶囊中对氨基酚和对氯苯乙酰胺的HPLC测定方法。方法:色谱柱:Accerasil C8(4. 6 mm×250mm,5μm);流动相:甲醇-磷酸盐缓冲液(磷酸氢二钠8. 95 g,磷酸二氢钠3. 9 g,加水溶解至1 000 mL,加10%四丁基氢氧化铵溶液12 mL),梯度洗脱;流速0. 8 mL·min~(-1);检测波长为240 nm;柱温35℃;进样量20μL。结果:对氨基酚浓度在0. 100 5~30. 15μg·mL~(-1)、对氯苯乙酰胺浓度在0. 096 6~11. 59μg·mL~(-1)范围内与峰面积线性关系良好(r≥0. 999 7),检测限分别为0. 17 ng、0. 14 ng,平均回收率分别为101. 60%、99. 05%(RSD≤0. 7%n=9)。结论:该方法专属性好、操作简便、快速准确,可用于氨咖黄敏胶囊中对氨基酚和对氯苯乙酰胺的检测,可为提高该药的质量控制技术提供参考。
Objective: To establish an HPLC method for determination of P-aminophenol and P-chloracetanilide in Paracetamol Caffein,Atificial Cow-bezaoar and chlorphenamine Maleate capsules. Methods: The eluate obtained was analyzed by HPLC method with Accerasil C_8( 4. 6 mm × 250 mm,5 μm),phosphate buffer solution-methanol as a mobile phase gradient elution. The flow rate was 0. 8 mL·min~(-1). The detection wave length was 240 nm,and the column temperature was 35 ℃. The injection volume was 20μL. Results: P-aminophenol and P-chloracetanilide showed good linearity in the ranges of 0. 100 5 ~ 30. 15、0. 096 6 ~ 11. 59 μg·mL~(-1)( r≥0. 999 7) respectively. The detection limit were 0. 17 ng、0. 14 ng respectively. The average recovery values values of P-aminophenol and P-chloracetanilide of were 101. 60% 、99. 05%( RSD≤0. 7%,n = 9) respectively. Conclusion: The method is simple with high accuracy and reproducible,which can be used for the determination P-aminophenol and P-chloracetanilide in Paracetamol Caffein,Atificial Cow-bezaoar and chlorphenamine Maleate capsules.
引文
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