高效液相色谱法测定美息伪麻拉明分散片中组分含量的研究

Studies on Quantitative Determination of Ingredients in “ Dextromethorphan Hydrobromide Diphenhydramine Hydrochloride Paracetamol Pseudoephedrine Hydrochloride Dispersed Tablets” by HPLC

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 establish an exteral standard HPLC method for the quantitative determination of parac-etamol, dextromethorphan hydrobromide, pseudoephedrine hydrochloride and diphenhydramine hydrochloride in ' Dextromethorphan Hydrobromide Diphenhydramine Hydrochloride Paracetamol Pseudoephedrine Hydrochloride dispersed tablets'. Methods: The chromatographic conditions were as follows; Diamonsil - C18 (200 mm ×4. 6 mm, 5 μm). The mobile phase consisted of a mixture of acetonitrile - methanol - 0. 05 mol · L-1 potassium di-hydrogen phosphate (5:1:25) for paracetamol and UV detection at 245 nm. The mobile phase consisted of a mix-ture of sodium formate buffer (pH=3. 3) acetonitrile - methanol - sodium lauryl sulfate (32:28: 5'0. 06 = V:V: V: W) for Dextromethorphan Hydrobromide Pseudoephedrine Hydrochloride and Diphenhydramine Hydrochloride and UV detection at 256 nm. Results: The calibration curves were linear in the range of 2. 06 -20. 60 μg · mL for paracetamol ( r = 0. 999 7 ) , 0. 11 -1. 06 mg · mL-1 for dextromethorphan hydrobromide (r = 0. 999 4 ) , 0. 20 -2. 02 mg · mL-1 for pseudoephedrine hydrochloride (r =0. 999 5) , 0. 10 -1.01 mg · mL-1 for diphenydramine hydrochloride (r =0. 999 7) . The average recoveries were 100. 2% , 99. 28% , 100. 6% and 100. 7% for four a-bove mentioned components respectively. Conclusion: The method is accurate and reliable for the quality control of this compound preparation.