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目的:采用高效液相色谱法考察并建立了测定复方制剂美息伪麻拉明分散片中对乙酰氨基酚(Par)、氢溴酸右美沙芬(Dex)、盐酸苯海拉明(Dip)和盐酸伪麻黄碱(Pse)的含量。方法:色谱柱为Diamonsil-C_(18)(200mm×4.6mm,5μm),测定Par用乙腈-甲醇-0.05mol·L~(-1)磷酸二氢钾溶液(5:1:25)为流动相,检测波长为245nm,测定Dex、Dip和Pse用pH3.3甲酸钠缓冲液-乙腈-甲醇-十二烷基硫酸钠(32:28:5:0.06=V:V:V:W)为流动相,检测波长为256nm。结果:Par、Dex、Pse、Dip浓度在2.06～20.60μg·mL~(-1),0.11～1.06,0.20～2.02,0.10～1.01mg·mL~(-1)范围内与峰面积呈良好的线性关系,r分别为0.999 7,0.999 4,0.999 5,0.999 7。平均回收率依次为100.2％,99.28％,100.6％,100.7％。结论:本法精密度好,结果准确可靠。适用于该复方制剂的质量检验分析。
OBJECTIVE: To investigate the inhibitory effect of acetaminophen (Par), dextromethorphan hydrobromide (Dex), diphenhydramine hydrochloride (Dip) And pseudoephedrine hydrochloride (Pse) content. METHODS: Diamonsil-C_ (18) (200 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase was eluted with acetonitrile-methanol-0.05 mol·L -1 potassium dihydrogen phosphate (5: 1: 25) Phase and the detection wavelength was 245 nm. Dex, Dip and Pse were determined to be mobile with pH3.3 sodium formate buffer-acetonitrile-methanol-sodium lauryl sulfate (32: 28: 5: 0.06 = V: V: V: W) Phase, detection wavelength of 256nm. Results: The concentrations of Par, Dex, Pse and Dip in the range of 2.06 ~ 20.60μg · mL ~ (-1), 0.11 ~ 1.06,0.20 ~ 2.02 and 0.10 ~ 1.01mg · mL ~ (-1) Linear relationship, r were 0.999 7,0.999 4,0.999 5,0.999 7. The average recoveries were 100.2%, 99.28%, 100.6% and 100.7%, respectively. Conclusion: The method has good precision and the result is accurate and reliable. Applies to the quality of the compound test analysis.