HPLC法测定盐酸西替伪麻缓释片的含量

Determination of Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Sustained-release Tablets by HPLC

目的：建立HPLC法测定盐酸西替伪麻缓释片中盐酸伪麻黄碱和盐酸西替利嗪的含量。方法：色谱柱为Hypersil ODS C18柱（4．6mm×250mm，5μm），流动相为乙腈-0．3％冰醋酸溶液-0.3％庚烷磺酸钠溶液（45：30：25），流速为1．0mL·min^-1，检测波长为244nm。结果：盐酸伪麻黄碱在360～1800mg·L^-1（r=1．000）范围内线性关系良好，平均回收率为99．3％（n=5），RSD为0．4％；盐酸西替利嗪在14～72mg·L^-1（r=1．000）范围内线性关系良好，平均回收率为98．7％（n=5），RSD为0．6％。结论：该方法简便、准确、快速，可同时测定两组分的含量。

Objective：To establish an HPLC method for determination of Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Sustained-release Tablets. Methods： The analytical column was Hypersil ODS C18 column（4. 6 mm × 250 mm,5μm）and the mobile phase was acetonitrile -0. 3% glacial acetic acid -0. 3% sodium heptanesulfonate （45： 30： 25） at a flow rate of 1.0 mL·min^-1. The UV detection wavelength was at 244 nm. Results： The linearity was good for Pseudoephedrine Hydrochloride within the range of 360 1 800 mg · L^-1 （r =1. 000） ,the mean recovery was 99. 3% （n =5）, RSD =0. 4% ; The linearity was good for Cetirizine Hydrochloride within the range of 14 -72 mg · L^-1 （r = 1. 000） ,the mean recovery was 98.7% （n =5）, RSD =0.6%. Conclusion： The method is simple and rapid for determination of two components in the drug.