BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD

A simple, rapid and convenient high performance liquid chromatographic method has been developed for the determination and bioequivalence of norfloxacin intablets formulations by using ciprofloxacin as an internal standard. The chromatographic separation was achieved on a C18 column having an isocra...

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Autores principales:	SHER,MUHAMMAD, AJAZ HUSSAIN,MUHAMMAD, MEHMOOD,MHAMMAD HAMMAD, HASSAN,MUHAMMAD NAEEMUL, BASHIR,SAJID
Lenguaje:	English
Publicado:	Sociedad Chilena de Química 2010
Materias:	Norfloxacin Bioequivalence HPLC-UV
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000200012
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spelling	oai:scielo:S0717-970720100002000122010-09-06BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHODSHER,MUHAMMADAJAZ HUSSAIN,MUHAMMADMEHMOOD,MHAMMAD HAMMADHASSAN,MUHAMMAD NAEEMULBASHIR,SAJID Norfloxacin Bioequivalence HPLC-UV A simple, rapid and convenient high performance liquid chromatographic method has been developed for the determination and bioequivalence of norfloxacin intablets 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 norfloxacin administered to healthy volunteers using a randomize 2x2 crossover design, pharmacokinetics parameters (AUC0-t, AUC0-∞, Cmax, t½ ) 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.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.55 n.2 20102010-06-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000200012en10.4067/S0717-97072010000200012
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Norfloxacin Bioequivalence HPLC-UV
spellingShingle	Norfloxacin Bioequivalence HPLC-UV SHER,MUHAMMAD AJAZ HUSSAIN,MUHAMMAD MEHMOOD,MHAMMAD HAMMAD HASSAN,MUHAMMAD NAEEMUL BASHIR,SAJID BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD
description	A simple, rapid and convenient high performance liquid chromatographic method has been developed for the determination and bioequivalence of norfloxacin intablets 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 norfloxacin administered to healthy volunteers using a randomize 2x2 crossover design, pharmacokinetics parameters (AUC0-t, AUC0-∞, Cmax, t½ ) 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.
author	SHER,MUHAMMAD AJAZ HUSSAIN,MUHAMMAD MEHMOOD,MHAMMAD HAMMAD HASSAN,MUHAMMAD NAEEMUL BASHIR,SAJID
author_facet	SHER,MUHAMMAD AJAZ HUSSAIN,MUHAMMAD MEHMOOD,MHAMMAD HAMMAD HASSAN,MUHAMMAD NAEEMUL BASHIR,SAJID
author_sort	SHER,MUHAMMAD
title	BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD
title_short	BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD
title_full	BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD
title_fullStr	BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD
title_full_unstemmed	BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD
title_sort	bioequivalence of norfloxacin by hplc-uv method
publisher	Sociedad Chilena de Química
publishDate	2010
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072010000200012
work_keys_str_mv	AT shermuhammad bioequivalenceofnorfloxacinbyhplcuvmethod AT ajazhussainmuhammad bioequivalenceofnorfloxacinbyhplcuvmethod AT mehmoodmhammadhammad bioequivalenceofnorfloxacinbyhplcuvmethod AT hassanmuhammadnaeemul bioequivalenceofnorfloxacinbyhplcuvmethod AT bashirsajid bioequivalenceofnorfloxacinbyhplcuvmethod
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BIOEQUIVALENCE OF NORFLOXACIN BY HPLC-UV METHOD

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