HPLC法测定布洛伪麻缓释片的释放量

Dissolution Determination of Ibuprofen and Pseudoephedrine Hydrochloride Sustained-release Tablets by HPLC

目的：建立高效液相色谱法测定布洛伪麻缓释片释放量的方法.方法：色谱柱为迪马C18（250 mm×4.6 mm,5μm）,流动相为甲醇.三乙胺-0.04 mol·L-1磷酸二氢钠溶液（60：0.02：40）,流速为1.0 ml·min-1,检测波长为215 nm,柱温为35℃,进样量为20μl.结果：布洛芬的线性范围为40～2 000 μg·ml-1（r=1.000 0）,平均加样回收率为99.2％,RSD=0.8％（n=9）,最低定量浓度为0.04μg· ml-1;盐酸伪麻黄碱的线性范围为6～300 μg· ml-1（r=1.000 0）,平均加样回收率为98.5％,RSD =0.6％ （n =9）,最低定量浓度为0.06μg·ml-1.结论：该方法简便快速、准确灵敏,可用于布洛伪麻缓释片释放量的测定.

Objective： To establish a method for the dissolution determination of ibuprofen and pseudoephedrine hydrochloride sus- tained-release tablets by HPLC. Methods： HPLC was adopted using a DIKMA C18 （250 mm × 4.6 mm,5 μm）column, the mobile phase consisted of methanol, triethylamine and 0.04 mol · L- 1 sodium dihydrogen phosphate solution （60： 0.02： 40） at the flow rate of 1.0 ml · min-1. The detection wavelength was 215nm. The column temperature was at 35℃ and the injection volume was 20 μl. Re- suits： A good linear correlation of ibuprofen was obtained within the range of 40-2 000 μg · ml - 1 （ r = 1. 000 0）, the average recovery was 99.2% with RSD of 0.8% （ n = 9 ）, and the limit of quantification was 0.04 μg · ml -1 The linear range of pseudoephedrine hydrochloride was 6-300 μg ·ml-1 （ r = 1. 000 0）, the average recovery was 98.5% with RSD of 0.6% （ n = 9）, and the limit of quantification was 0.06μg · ml-1. Conclusion： The method is rapid, simple, sensitive and accurate. It can be used to determine the released amount of ibuprofen and pseudoephedrine hydrochloride sustained-release tablets.