论文部分内容阅读
目的 建立同时测定布洛伪麻颗粒剂中布洛芬和盐酸伪麻黄碱含量的反相HPLC测定法。方法 以双氯芬酸为内标 ;色谱柱为Shim packCLC DOS柱 ,流动相为甲醇 磷酸盐缓冲液 (含 0 .0 5mol·L- 1 磷酸二氢钾和 0 .0 1mol·L- 1 磷酸氢二钾 ) (6 4∶36 ) ,流速为 1.0ml·min- 1 ,定时程序控制检测波长 (0～ 6min为 2 15nm ,6～ 10min为 2 6 0nm) ;进样量 2 0 μl。结果 布洛芬和盐酸伪麻黄碱分别在 0 .0 2～ 0 .40mg·ml- 1 和 3.0～ 6 0 .0 μg·ml- 1 范围内线性关系良好 ,相关系数分别为r =0 .9997和r=0 .9998。两组分的回收率分别介于 98.0 2 %～ 10 1.12 %和 97.71%～ 10 1.15 %之间 ,日内和日间RSD均低于 5 %。结论 本法可同时测定布洛伪麻颗粒剂中布洛芬和盐酸伪麻黄碱的含量 ,而且简便、准确、快速 ,可用于多批样品的含量测定及质量控制。
OBJECTIVE To establish a reverse phase HPLC method for the simultaneous determination of ibuprofen and pseudoephedrine hydrochloride in buluojime granules. Methods Diclofenac was used as internal standard. The chromatographic column was Shim packCLC DOS. The mobile phase consisted of methanol phosphate buffer (containing 0. 05mol·L-1 potassium dihydrogen phosphate and 0. 01mol·L-1 dipotassium hydrogen phosphate ) (6 4:36) at a flow rate of 1.0 ml · min-1. The detection wavelength was controlled by a timing program (2 15 nm for 0-6 min and 260 nm for 6-10 min). The injection volume was 20 μl. Results There was a good linear relationship between ibuprofen and pseudoephedrine hydrochloride in the range of 0.2 ~ 0.40 mg · ml-1 and 3.0 ~ 6.0 μg · ml-1, respectively, the correlation coefficients were r = 0.9997 and r = 0 .9998. The recoveries of the two components ranged from 98.0 2% to 10 1.12% and 97.71% to 10 1.15%, respectively. The RSDs of the two components were lower than 5% within and between days. Conclusion This method can simultaneously determine the contents of ibuprofen and pseudoephedrine hydrochloride in buluojime granules and is simple, accurate and rapid and can be used for the determination and quality control of multiple batches of samples.