布洛伪麻分散片的溶出度测定

Determination of Dissolution of Ibuprofen and Pseudoephedrine Hydrochloride Dispersible Tablets

建立了布洛伪麻分散片的溶出度检查方法。考察在不同的溶出介质、转速下布洛伪麻分散片中布洛芬和盐酸伪麻黄碱的溶出情况,确定了溶出参数:照中国药典2010年版溶出度第二法装置,以pH 5.5的磷酸盐缓冲液900 ml为溶出介质,转速50 r/min。采用HPLC法测定每片中布洛芬和盐酸伪麻黄碱的溶出量。使用C18色谱柱,流动相为乙腈-水(1︰1)(每1 000 ml含十二烷基磺酸钠2.5 g,加磷酸1 ml,混匀后用氨水调至pH 3.2),检测波长215 nm。布洛芬和盐酸伪麻黄碱在10～1 000μg/ml和1.5～150μg/ml范围内线性关系良好,回收率为98.1%和100.4%,RSD为2.6%和0.4%。

The dissolubilities of ibuprofen and pseudoephedrine hydrochloride dispersible tablets in different dissolution mediums and different rotation speeds were discussed. The dissolution method was determined as follows： using the second dissolution method in Chinese Pharmacopoeia 2010 edition, at the rotation speed of 50 r/min and with the phosphate buffer solution （pH 5.5） of 900 ml. Ibuprofen and pseudoephedrine hydrochloride were detemined by HPLC. A C18 column was used with the mobile phase of acetonitrile-water （1 ： 1） （containing sodium dodecyl sulfate 2.5 g and phosphoric acid 1 ml dissolved in 1 000 ml, adjusted to pH 3.2 with ammonia） at the detection wavelength of 215 nm. The calibration curves of ibuprofen and pseudoephedrine hydrochloride were linear in the concentration ranges of 10 -1 000μg/ml and 1.5 -150 μg/ml. The recoveries were 98.1% and 100.4%, with RSDs of 2.6% and 0.4%.