HPLC法测定卡巴拉汀贴剂中药物含量及其体外透皮释放量

建立了一种卡巴拉汀贴片含量及其体外透皮释放量的高效液相色谱（HPLC）测定法,并用离体豚鼠皮肤为透皮屏障,采用改进 Franz 扩散池,研究卡巴拉汀透皮贴剂体外透皮性能。结果表明,卡巴拉汀在 9.69~116.32 μg/mL 浓度范围内线性关系良好,检测限为 0.17 μg/mL,精密度RSD 为 0.12%~0.47%,低、中、高 3 个浓度的平均回收率分别为 98.79%、98.59%、99.88%;该贴剂体外透皮释放曲线符合零级方程(Q=kt),为 Q =59.91t +6.02,r = 0.9987。所建立的 HPLC 方法灵敏、准确、操作简便,可有效测定卡巴拉汀贴剂的含量及其体外透皮释放量。

HPLC determination of rivastigmine in patches and the skin permeation behavior of the transdermal delivery system in vitro

The HPLC method has been employed for the determination of rivastigmine in rivastigmine patches, and the skin permeation behavior of the patches was studied in vitro using a modified Franz diffusion pool and excised guinea pig skins. The results showed that the linear range was 9.69~116.32 μg/mL (r =0.9999)with a limit of detection (LOD) of 0.17 μg/mL. The relative standard deviations (RSD) were 0.12%-0.47%. In the low, medium and high concentration ranges, the average recoveries of rivastigmine were 98.79%, 98.59%, 99.88% respectively. The cumulative permeation curves for the rivastigmine transdermal delivery system (TDDS) were demonstrated to obey a zero order equation (Q=kt), of the form Q =59.91t +6.02, r = 0.9987. This method is simple, rapid, sensitive and accurate. It can be used to determine rivastigmine in a TDDS.