Pharmacokinetic studies of metformin and glibenclamide in normal human volunteers.
نویسندگان
چکیده
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).
منابع مشابه
ارزیابی فارماکوکینتیک و فارماکودینامیک قرص پانصد میلی گرمی متفورمین هیدروکلراید در داوطلبان سالم
Background: Metformin is used in treatment of non-insulin-dependent diabetes mellitus (NIDDM). The present study was aimed to study the pharmacokinetic and pharmaco-dynamic of metformin 500 mg tablet in healthy volunteers. Methods: The test and reference metformin hydrochloride 500 mg tablets were administered to 12 healthy volunteers in a cross-over study. Metformin serum concentration and dec...
متن کاملBioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers
Glimepiride/metformin(2/500mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin(2/500mg) fixed-dose combination(FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerabi...
متن کاملBioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers
Glimepiride/metformin(2/500mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin(2/500mg) fixed-dose combination(FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerabi...
متن کاملComparative Pharmacokinetics of Levofloxacin in Healthy Volunteers and in Patients Suffering from Typhoid Fever
The aim of this study was to characterize the effect of typhoid fever on pharmacokinetic parameters of levofloxacin (LF) and compare the pharmacokinetic parameters of the said antibiotic in healthy human volunteers and patients with typhoid fever. Total of 12 subjects were divided into two groups “A” (healthy volunteers) and “B” (typhoid patients). Single oral dose of LF 500 mg was given and 5 ...
متن کاملComparative Pharmacokinetics of Levofloxacin in Healthy Volunteers and in Patients Suffering from Typhoid Fever
The aim of this study was to characterize the effect of typhoid fever on pharmacokinetic parameters of levofloxacin (LF) and compare the pharmacokinetic parameters of the said antibiotic in healthy human volunteers and patients with typhoid fever. Total of 12 subjects were divided into two groups “A” (healthy volunteers) and “B” (typhoid patients). Single oral dose of LF 500 mg was given and 5 ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Pakistan journal of pharmaceutical sciences
دوره 27 1 شماره
صفحات -
تاریخ انتشار 2014