Method development and validation of repaglinide in human plasma by HPLC and its application in pharmacokinetic studies.

Abstract:

:In this study, the development and validation of a high-performance liquid chromatography (HPLC) assay for determination of repaglinide concentration in human plasma for pharmacokinetic studies is described. Plasma samples containing repaglinide and an internal standard, indomethacin were extracted with ethylacetate at pH 7.4. The recovery of repaglinide was 92%+/-55.31. Chromatographic separations were performed on Purospher STAR C-18 analytical column (4.8 mm x 150 mm; 5 microm particle size). The mobile phase composed of acetonitrile-ammonium formate (pH 2.7; 0.01 M) (60:40, v/v). The flow rate was 1 ml/min. The retention time for repaglinide and indomethacin were approximately 6.2 and 5.3 min, respectively. Calibration curves of repaglinide were linear in the concentration range of 20-200 ng/ml in plasma. The limits of detection and quantification were 10 ng/ml and 20 ng/ml, respectively. The inter-day precision was from 5.21 to 11.84% and the intra-day precision ranged from 3.90 to 6.67%. The inter-day accuracy ranged 89.95 to 105.75% and intra-day accuracy ranged from 92.37 to 104.66%. This method was applied to determine repaglinide concentration in human plasma samples for a pharmacokinetic study.

journal_name

J Pharm Biomed Anal

authors

Ruzilawati AB,Wahab MS,Imran A,Ismail Z,Gan SH

doi

10.1016/j.jpba.2006.12.010

subject

Has Abstract

pub_date

2007-04-11 00:00:00

pages

1831-5

issue

5

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(06)00799-0

journal_volume

43

pub_type

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