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目的:建立HPLC法测定小儿氨酚黄那敏颗粒中对乙酰氨基酚和马来酸氯苯那敏含量,并考察其含量均匀度。方法:色谱柱:waters C_(18)(150 mm×4.6 mm,5μm);流动相:甲醇-磷酸二氢钾溶液-三乙胺(15:85:0.02)(磷酸调pH至3.3);检测波长:215 nn;流速:1.0 ml·min~(-1);进样量:10μl。结果:对乙酰氨基酚的线性范围1.000～4.000 mg·ml~(-1)(r=0.999 7),平均回收率为101.7%,RSD=1.8%;3批样品的平均含量分别为102.8%,102.4%,103.5%,含量均匀度分别为5.9,5.5,2.7。马来酸氯苯那敏线性范围0.006～0.018 mg·ml~(-1)(r=0.999 7),平均回收率为98.7%,RSD=2.0%;3批样品的平均含量分别为100.1%,98.9%,97.9%,含量均匀度分别为4.6,3.9,7.0。结论:测定方法简便,重复性好,精密度高,可以用于小儿氨酚黄那敏颗粒的质量控制。
OBJECTIVE: To establish an HPLC method for the determination of paracetamol and chlorpheniramine maleate in paracetamol, Huangnaomin granule and to investigate the content uniformity. (Mobile phase: methanol-potassium dihydrogen phosphate-triethylamine (15: 85: 0.02) Wavelength: 215 nn; flow rate: 1.0 ml · min -1; injection volume: 10 μl. Results: The linear range of paracetamol ranged from 1.000 to 4.000 mg · ml -1 (r = 0.999 7) with an average recovery of 101.7% and RSD of 1.8%. The average contents of three samples were 102.8% 102.4%, 103.5%, content uniformity were 5.9,5.5,2.7. The linear range of chlorpheniramine maleate was 0.006-0.018 mg · ml -1 (r = 0.999 7) with the average recovery of 98.7% and RSD 2.0%. The average contents of three batches of samples were 100.1% 98.9%, 97.9%, content uniformity were 4.6,3.9,7.0. Conclusion: The method is simple, reproducible and accurate. It can be used for the quality control of paracetamol and Huangnaomin granule in children.