Rashid Ayesha, Ahmad Mahmood, Minhas Muhammad Usman, Hassan Ijaz Javed, Malik Muhammad Zubair
Department of Pharmacy, the Islamia University of Bahawalpur, Bahawalpur, Pakistan.
Department of Physiology & Pharmacology, University of Agriculture, Faisalabad, Pakistan.
Pak J Pharm Sci. 2014 Jan;27(1):153-9.
The study was aimed to evaluate various pharmacokinetic parameters of a commercially available fixed dose combination of oral antidiabetics (Metformin/Glibenclamide 500/5mg tablets) in plasma sample of normal healthy adult male volunteers by applying an accurate, selective, and reproducible HPLC-UV analytical method for quantification of Metformin HCL and Glibenclamide simultaneously in a single chromatographic run. Previously no HPLC-UV analytical method for simultaneous estimation of Metformin/Glibenclamide has been reported in Pakistan. The human plasma samples were evaluated by using an isocratic High Performance Liquid Chromatography (HPLC) system of Sykam consisted of a pump with a column of Thermo Electron Corporation USA (ODS hypersil C18 4.6 mm x 250 mm), a UV-detector with data processing Clarity software. The mobile phase of 0.040M Potassium dihydrogen phosphate containing 0.25mL/L triethylamine at pH 3.5 (adjusted with 1:1 phosphoric acid) and acetonitrile (465: 535v/v) was delivered with injection volume of 100μL at flow rate of 1 mL/min at 25°C temperature. The detection was performed at λmax230 nm. By applying this method, important pharmacokinetic parameters Cmax, Tmax, AUCo-oo, AUMCo-oo, t1/2, Ke, MRT, Vdand CIT are calculated. Maximum plasma concentrations Cmax was 131.856±8.050ng/ml for Glibenclamide (Mean ± SEM) and 511.106±12.675 ng/ml for Metformin HCl (Mean ±SEM).
本研究旨在通过应用一种准确、选择性和可重复的高效液相色谱-紫外（HPLC-UV）分析方法，在一次色谱运行中同时定量测定盐酸二甲双胍和格列本脲，以评估市售口服抗糖尿病固定剂量复方制剂（二甲双胍/格列本脲500/5mg片剂）在正常健康成年男性志愿者血浆样本中的各种药代动力学参数。此前在巴基斯坦尚未有关于同时测定二甲双胍/格列本脲的HPLC-UV分析方法的报道。使用Sykam等度高效液相色谱（HPLC）系统对人血浆样本进行评估，该系统由一台泵、一根美国热电电子公司的色谱柱（ODS hypersil C18 4.6 mm×250 mm）以及一台配备数据处理Clarity软件的紫外检测器组成。流动相为含0.25mL/L三乙胺、pH 3.5（用1:1磷酸调节）的0.040M磷酸二氢钾和乙腈（465:535 v/v），进样体积为100μL，流速为1 mL/min，温度为25°C。检测在λmax230 nm处进行。通过应用该方法，计算出重要的药代动力学参数Cmax、Tmax、AUCo-∞、AUMCo-∞、t1/2、Ke、MRT、Vd和CIT。格列本脲的最大血浆浓度Cmax为131.856±8.050ng/ml（均值±标准误），盐酸二甲双胍的最大血浆浓度Cmax为511.106±12.675 ng/ml（均值±标准误）。
