文摘

稳定的发展和验证indicatingHPLCmethod adapalene和苯甲酸pharmaceuticalGel配方

作者(年代):M。Mudasir, N。Tabassum, J。阿里,R.Jan

一个简单的、有选择性的、精确的和stability-indicating高性能adapalene色谱法分析和苯甲酸在制药(凝胶)配方的开发。流动相由乙腈(ACN),四氢呋喃(四氢呋喃)和磷酸盐缓冲剂(PB) (pH值- 3.0;0.01米)。Thismobile阶段给予足够的结果被发现峰的形状,对称,切线和尾矿。保留时间(RT) adapalene和苯甲酸被发现8.8(±1)和2.2 (±1)。样品受到酸、碱水解、氧化、热、湿度、光降解。整个分析进行定时的波长230 nm和272 nm)分别对苯甲酸和adapalene。的线性回归分析数据校准块显示良好的线性关系与r2 = 0.9995和0.9998分别adapalene和苯甲酸对峰面积分别浓度范围的14-26ig / ml adapalene和28-52ig / ml苯甲酸。相关系数的平均值;斜率和截距分别为0.9995、9060.51和1282年adapalene为0.9998、10185.77和1302分别为苯甲酸。 Themethod was validated for precision, specificity, recovery and robustness, in accordance with ICH guidelines. The drug undergoes degradation under basic and thermal conditions. This indicates that the drug is susceptible to base hydrolysis, and thermal degradation. Statistical analysis proves that the method is reproducible, selective and accurate for the estimation of said drug. As the method could effectively separate the drug fromits degradation product, it can be employed as a stability-indicating one.