HPLC法测定卡巴拉汀贴剂中药物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

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9．69～116．32μg／mL浓度范围内线性关系良好，检测限为0．17μg／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。

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.