BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD

التفاصيل البيبلوغرافية
العنوان: BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD
المؤلفون: Mhammad Hammad Mehmood, Muhammad N. Hassan, Muhammad Sher, Muhammad Ajaz Hussain, Sajid Bashir
المصدر: Journal of the Chilean Chemical Society, Volume: 55, Issue: 2, Pages: 203-205, Published: JUN 2010
Journal of the Chilean Chemical Society v.55 n.2 2010
SciELO Chile
CONICYT Chile
instacron:CONICYT
بيانات النشر: Sociedad Chilena de Química, 2010.
سنة النشر: 2010
مصطلحات موضوعية: Detection limit, Chromatography, HPLC-UV, Chemistry, General Chemistry, Bioequivalence, Crossover study, chemistry.chemical_compound, Pharmacokinetics, Linear range, medicine, Methanol, Phosphoric acid, Norfloxacin, medicine.drug
الوصف: A simple, rapid and convenient high performance liquid chromatographic method has been developed for the determination and bioequivalence of norfloxacin in tablets formulations by using ciprofloxacin as an internal standard. The chromatographic separation was achieved on a C18 column having an isocratic mixture of methanol, disodium hydrogen phosphate buffer and acetonitrile (30:30:40) at pH 3 adjusted with o -phosphoric acid. The eluents were detected at 280 nm and quantitation was achieved on the basis of peak height ratio of norflaoxacin and internal standard. Limit of detection of the method developed was 15 ng mL -1 with a linear range of 30 – 200 ng mL -1 . After single oral dose (400 mg) of two formulations (Noroxin, MSD and Ecoflaxin, Technovision Pharmaceutical) of norfloxa-cin administered to healthy volunteers using a randomize 2×2 crossover design, pharmacokinetics parameters (AUC 0-t , AUC 0-∞ , C max , t 1/2 ) were derived from the plasma concentrations curves for both formulations. Pharmacokinetic analysis of the data showed that the two formulations were bioequivalent, while no adverse reactions to drug were observed. In addition, the method evolved has been found suitable for the routine quality control tests.
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اللغة: English
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b390f7dda9b373f11c5db9b6761ca251
http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000200012&lng=en&tlng=en
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....b390f7dda9b373f11c5db9b6761ca251
قاعدة البيانات: OpenAIRE