摘要
目的:建立同时测定布洛芬盐酸苯海拉明口腔崩解片中布洛芬和盐酸苯海拉明含量的方法。方法:采用反相高效液相色谱法。色谱柱为Shim-pack VP-ODSC18m流动相为0.05mol/L磷酸二氢钾溶液-乙腈-冰乙酸-三乙胺(54:46:0.2:0.2,V/V/V/V),流速为1.0ml/min,检测波长为263nm,柱温为30℃,进样量为20μl。结果:布洛芬和盐酸苯海拉明的检测质量浓度分别在100~1000、7.5~120μg/ml范围内与各自峰面积积分值呈良好的线性关系(r=0.9998和0.9999);精密度、稳定性、重复性试验的RSD≤0.98%;平均回收率分别为98.52%、99.07%,RSD分别为0.22%、0.87%(n=9)。结论:该方法简便灵敏、快速准确、专属性强,可用于同时测定布洛芬盐酸苯海拉明口腔崩解片中布洛芬和盐酸苯海拉明的含量。
OBJECTIVE: To establish a method for simultaneous determination of ibuprofen and diphenhydramine hydrochlo-ride in Ibuprofen and diphenhydramine oral disintegrating tablets. METHODS: RP-HPLC method was adopted. The separation was performed on Shim-pack VP-ODS C18 column with mobile phase consisted of 0.05 mol/L potassium dihydrogen phosphate buf-fer-acetonitrile-glacial acetic acid-triethylamine (54:46:0.2:0.2, V/V/V/V) at the flow rate of 1.0 ml/min; the detection wavelength was set at 263 nm and the column temperature was 30 ℃ ; the sample size was 20 μl. RESULTS: The linear ranges were 100-1 000 μg/ml for ibuprofen (r=0.999 8) and 7.5-120 μg/ml for diphenhydramine hydrochloride (r=0.999 9) ; RSDs of preci-sion, reproducibility and stability tests were lower than 0.98%. The average recoveries were 98.52% (RSD=0.22%, n=9) and 99.07 % (RSD = 0.87%, n=9). CONCLUSIONS: The method is simple, rapid, accurate and specific. It can be used for simultane-ous determination of 2 components in Ibuprofen and diphenhydramine oral disintegrating tablets.
出处
《中国药房》
CAS
CSCD
2014年第16期1519-1521,共3页
China Pharmacy