摘要
建立了同时测定布洛芬和苯海拉明的含量反相高效液相法,确定以C18柱,流动相为乙腈-磷酸盐缓冲盐-甲醇为3∶2∶5,流速为1.0 mL.min-1,检测波长为210 nm的色谱条件;通过对溶出转速、介质和溶出曲线等条件考察,建立了本软胶囊溶出度的测定方法。结果:布洛芬在55.1～551μg.mL-1浓度范围内呈良好的线性关系,苯海拉明在6.9～69μg.mL-1浓度范围内呈良好的线性关系,布洛芬和盐酸苯海拉明的平均回收率分别100.8%±0.7%和101.4%±0.6%,溶出度测定结果限度为30 min大于标示量的80%。
A RP-HPLC method was developed and validated for the simultaneous determination of ibuprofen and diphenhydramine hydrochloride in the dissolution medium. The chromatographic separation was achieved on a C18 column using acetonitrile-methanol- PBS at pH 3.5 （3：2：5, v/v） as the mobile phase with the flow rate at 1.0 mL·min^-1. The detective wavelength was 215 nm. The effects of the conditions such as rotation rate and dissolution medium on the dissolution curves of the drugs were investigated. The linear quantitation ranges of ibuprofen and diphenhydramine hydrochloride were 55.1-551μg·mL^-1 and 6.9- 69 μg·mL^-1, respectively. The mean recoveries were 100.8%±0.7% for ibuprofen and 101.4%±0.6% for diphenhydramine hydrochloride. The dissolution limitation was over 80% of the labeled amount within 30 min.
出处
《药学与临床研究》
2013年第1期42-44,共3页
Pharmaceutical and Clinical Research
