Optimization and Validation of an RP-HPLC Method for Direct Determination of Metformin Hydrochloride in Human Urine and in a Dosage Form

A simple, selective, sensitive, accurate, and precise method was developed for determination of metformin hydrochloride (MF) in human urine using RP-HPLC. The method depends upon using an octylsilyl (C8) 5 microm particle size column at ambient temperature with mobile phase consisting of 33 mM sodiu...

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Bibliographic Details
Published inJournal of AOAC International Vol. 93; no. 6; pp. 1821 - 1828
Main Authors EL-GINDY, Alaa, MOHAMMED WAFAA NASSAR, NASR MOHAMMED EL-ABASAWY, KHALID ABDEL-SALAM ATTIA, AL-SHABRAWI, Maisra
Format Journal Article
LanguageEnglish
Published Gaithersburg, MD AOAC International 01.11.2010
Oxford University Press
Subjects
Acetonitriles
Adult
Analysis
Biological and medical sciences
Calibration
Chromatography, High Pressure Liquid
Drug Stability
Food industries
Freezing
Fundamental and applied biological sciences. Psychology
High performance liquid chromatography
Humans
Hydrogen-Ion Concentration
Hypoglycemic Agents - analysis
Hypoglycemic Agents - urine
Indicators and Reagents
Kinetics
Male
Metformin
Metformin - analysis
Metformin - urine
Physiological aspects
Reference Standards
Reproducibility of Results
Solubility
Spectrophotometry, Ultraviolet
Tablets
Temperature
Urine
United Arab Emirates
Human
Urine
Validation
Biological fluid
HPLC chromatography
Dosage form
Metformin
Method
Optimization
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Summary:A simple, selective, sensitive, accurate, and precise method was developed for determination of metformin hydrochloride (MF) in human urine using RP-HPLC. The method depends upon using an octylsilyl (C8) 5 microm particle size column at ambient temperature with mobile phase consisting of 33 mM sodium dihydrogen phosphate containing 6.38 mM hexanesulfonic acid sodium salt and adjusted to apparent pH 3.0 with phosphoric acid-acetonitrile (93 + 7, v/v) at a flow rate of 1.5 mL/min. Quantitation was achieved with UV detection at 231 nm based on peak area with a linear calibration curve over the concentration range of 0.01-50 microg/mL. The proposed method was applied to the determination of the urinary excretion pattern of MF (the cumulative amounts excreted were calculated without pretreatment of the urine sample) and for determination of the dissolution pattern of MF tablets. The proposed method was completely validated according to the U.S. Food and Drug Administration guidelines.
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ISSN:1060-3271
1944-7922
DOI:10.1093/jaoac/93.6.1821