RP-HPLC双波长法同时测定西替伪麻缓释片中2组分含量

Simultaneous Determination of Two Compounds in Cetirizine/Pseudoephedrine Sustained-release Tablets by Dual-wavelength RP-HPLC

目的:建立同时测定西替伪麻缓释片中盐酸伪麻黄碱(PEH)和盐酸西替利嗪(CTH)含量的方法。方法:采用反相高效液相色谱双波长法。色谱柱为DiamonsilTM C18,流动相为乙腈-0.02mol.L-1醋酸钠水溶液-高氯酸-三乙胺=40:60:0.5:0.1(pH为5.2±0.2),流速为1mL.min-1,PEH的检测波长为257nm,CTH的检测波长为230nm。结果:PEH和CTH检测浓度线性范围分别为0.05～0.3mg.mL-1(r=0.9999)、4～14μg.mL-1(r=0.9998),低、中、高3个浓度回收率分别为98.8%、98.6%、99.2%(RSD<0.61%)和100.2%、98.9%、99.3%(RSD<1.06%)。结论:本法简单、准确且重复性好,可用于西替伪麻缓释片中2组分的含量测定。

OBJECTIVE： To establish a method to determine the contents of pseudoephedrine hydrochloride （PEH） and cetiri- zinc hydrochloride （CTH） in Cetirizine/pseudoephedrine sustained-release tablets simultaneously. METHODS Dual-wavelength RP-HPLC method was adopted. DiamonsilTM C,8 column was used with acetonitrilel-0.02 mol. L-1 water solution of sodium ace- tate-perchloric acid-triethylamine （40 ： 60 ： 0.5 ： 0.1, pH adjusted to 5.2 ± 0.2） at the flow rate of 1 mL. vain- 1. The detection wave- lengths were set at 257 nm for PEH and 230 nm for CTH. RESULTS： The linear ranges were 0.05-0.3 mg.mL-1 for PEH （r= 0.999 9） and 4-14 μg.mL-1 for CTH （r=0.999 8）. Recovery rates of low, middle and high concentrations were 98.8%, 98.6% and 99.2% for PEH （RSD〈0.61%） and 100.2%, 98.9% and 99.3% for CTH （RSD〈1.06%）, respectively. CONCLUSION： The method is simple, accurate and reproducible, and can be used for the content determination of two compounds in Cetirizine/ pseudoephedrine sustained-release tablets.