Foroutan S M, Zarghi A, Shafaati A, Khoddam A
Department of Pharmaceutics, School of Pharmacy, Shaheed Beheshti University of Medical Sciences, Tehran, Iran.
J Pharm Biomed Anal. 2006 Oct 11;42(4):513-6. doi: 10.1016/j.jpba.2006.05.003. Epub 2006 Jun 23.
A simple, rapid and sensitive isocratic reversed phase HPLC method with UV detection using a monolithic column has been developed and validated for the determination of gliclazide in human plasma. The assay enables the measurement of gliclazide for therapeutic drug monitoring with a minimum quantification limit of 10ngml(-1). The method involves simple, one-step extraction procedure and analytical recovery was complete. The separation was carried out in reversed-phase conditions using a Chromolith Performance (RP-18e, 100mmx4.6mm) column with an isocratic mobile phase consisting of 0.01M disodium hydrogen phosphate buffer-acetonitrile (52:48, v/v) adjusted to pH 4.0. The wavelength was set at 230nm. The calibration curve was linear over the concentration range 10-5000ngml(-1). The coefficients of variation for inter-day and intra-day assay were found to be less than 6.0%.
已开发并验证了一种使用整体柱、带紫外检测的简单、快速且灵敏的等度反相高效液相色谱法，用于测定人血浆中的格列齐特。该测定法能够测定格列齐特以进行治疗药物监测，最低定量限为10ng/ml。该方法涉及简单的一步萃取程序，且分析回收率完全。分离在反相条件下进行，使用Chromolith Performance（RP - 18e，100mm×4.6mm）柱，等度流动相由0.01M磷酸氢二钠缓冲液 - 乙腈（52:48，v/v）组成，pH值调至4.0。波长设定为230nm。校准曲线在10 - 5000ng/ml浓度范围内呈线性。日间和日内测定的变异系数均小于6.0%。
