HPLC-UV determination of metformin in human plasma for application in pharmacokinetics and bioequivalence studies.
In this study, a simple, rapid and sensitive HPLC method with UV detection is described for determination of metformin in plasma samples from bioequivalence assays. Sample preparation was accomplished through protein precipitation with acetonitrile and chromatographic separation was performed on a reversed-phase phenyl column at 40 degrees C. Mobile phase consisted of a mixture of phosphate buffer and acetonitrile at flow rate of 1.0 ml/min. Wavelength was set at 236 nm. The method was applied to a bioequivalence study of two drug products containing metformin, and allowed determination of metformin at low concentrations with a higher throughput than previously described methods.
Porta
Valentina
V
Department of Pharmacy, College of Pharmaceutical Sciences, University of São Paulo, Av. Prof. Lineu Prestes 580, Bl. 13/15, 05508-900 São Paulo, SP, Brazil. vporta@usp.br
Schramm
Simone Grigoleto
SG
Kano
Eunice Kazue
EK
Koono
Eunice Emiko
EE
Armando
Yara Popst
YP
Fukuda
Kazuo
K
Serra
Cristina Helena Dos Reis
CH
D000097:Acetonitriles / Q000737:chemistry; D000284:Administration, Oral; D019540:Area Under Curve; D002138:Calibration; D011232:Chemical Precipitation; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006207:Half-Life; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D008687:Metformin / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013810:Therapeutic Equivalency; D013997:Time Factors
D000097:Acetonitriles; D007004:Hypoglycemic Agents; D008687:Metformin