离子对-反相高效液相色谱法测定布洛伪麻分散片的溶出度

Determination the Dissolution of Ibuprofen and Pesudoephedrine Hydrochloride Dispersible Tablets by IP-RP HPLC

目的:建立离子对-反相高效液相色谱法(IP-RPHPLC)测定布洛伪麻分散片溶出度的方法。方法:采用溶出度第三法(小杯法),以醋酸盐冲液(pH=7.2)为溶出介质。色谱柱为KromasilC18柱(4.6mm×150mm,5μm);流动相为醋酸-醋酸钠缓冲液-乙腈(4∶6),每1000mL流动相溶解十二烷基硫酸钠1.0g;检测波长为257nm。以外标法测定布洛伪麻分散片溶出液中布洛芬和盐酸伪麻黄碱的浓度,并计算相应时间内的累积溶出百分率。结果:布洛芬和盐酸伪麻黄碱分别在0.15～1.5mg/mL和0.025～0.25mg/mL范围内,浓度与峰面积呈良好的线性关系(r=0.9999和0.9993),平均回收率分别为100.1%(RSD=0.7%,n=9)和100.6%(RSD=0.8%,n=9)。结论:IP-RPHPLC法简便,重现性好。

Objective:To establish a HPLC method for determination of the dissolution of ibuprofen and pseudoephedrine hydrochloride dispersible tablets.Methods:The third method was adopted(Chinese pharmacopoeia2000edition).The release characteristic was evaluated in buffer solution of acetate(pH =7.2).The column was C 18 .The mobile phase was acetic acid -sodium acetate buffer solution -acetonitrile(4∶6).1.0g sodium laurysulfate was dissolved in1000mL mobile phase.The detection wavelength was257nm.Ibuprofen and pseudoephedrine hydrochloride were determined in dissolution medium by external standard method and accumulated release rate was calculated.Results:The standard curve of ibuprofen and pseudoephedrine hydrochloride were linear in the range of 0.15～1.5mg /mL,r=0.9999and0.025～0.25mg /mL,r=0.9993.And the average recovery were100.1%(RSD=0.7%,n=9)and100.6%(RSD=0.8%,n=9),respectively.Conclusion:The method is simple,accurate and reproducible.