HPLC测定复方氯伪缓释胶囊中两组分的含量

Determination of Pseudoephedrine Hydrochloride and Loratadine in the compound suslained-release capsules by HPLC

目的建立HPLC测定复方氯伪缓释胶囊两组分含量的方法.方法色谱柱为Platinum EPS C18(150 mm×4.6mm,5μm);甲醇-水-二乙胺(830:170:0.25,用磷酸调pH 4.5)为流动相;检测波长为210 nm.结果盐酸伪麻黄碱与氯雷他定分别在94.6～l44.6μg/ml与4.2～6.2μg/ml范围内呈良好线性关系,相关系数r分别为r=0.9995和0.9998.平均回收率分别为99.8%和98.5%(RSD分剐为0.42%和1.13%).结论该法简便、快捷、精密度高、重复性好,适用于本品的日常检测工作.

Objective To establish a HPLC method of Pseudoephedrine Hydrochloride and Loratadine in the compound sustained-release capsules. Method The speration was performed on a Platinum EPS C,s（ 150 nm ×4.6 nm,5μm）. The mobile phase was consisted of methyl alcohol-water-ethylenediamene （830 ： 170 ： 0.25, pH 4.5 adjusted with H3 PO4 ）. The flow rate was 1.0 ml/min and the detective wavelength was 210 nm. Column temperature was room temperature. Results It appears to have a good linearity within the concentration range of 94.6 × 144.6 μg/ml for PSD （ r = 0.9995 ） and 4.2 × 6.2 μg/ml for Loratadine （ r = 0.9998） respectively. The average recoveries were 99.8% and 98.5%, and relative standard deviation （RSD） was 0.42% and 1.13%. Conclusion The method was found to be simple, sensitive and accurate.