Editor-in-Chief İlkay Küçükgüzel Associate Editor Esra Tatar Online ISSN 2630-6344 Publisher Marmara University Frequency Bimonthly (Six issues / year) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal 2015 , Vol 19 , Issue 2
Development and validation of an HPLC method for determination of nateglinide in drug substances
Aylin HACIOGLU1, Aysin CITLAK1, Sevgi KARAKUS1
1Marmara University, Faculty of Pharmacy, Department of Pharmaceutical Chemistry, Haydarpaşa 34668 İstanbul, Turkey DOI : 10.12991/mpj.2015199640 The scope of this study was the development and validation of a reliable, rapid, simple, sensitive, precise reversed-phase high performance liquid chromatography (RP-HPLC) method for the determination of nateglinide in drug substances. The method was developed on ACE C18 analytical column (150 x 4.6 mm i.d., particle size 5.0 μm) using a mobile phase of acetonitrile and 0.05% trifluoroacetic acid (25:25, v/v). The eluent was monitored with UV detection at 210 nm at a flow rate of 1.5 mL/min. Calibration curve was linear between the concentration range of 0.2846-1.0125 mg/mL. The retention time of Nateglinide was 7.07 min and the correlation coefficient (r) of the regression equation for the Nateglinide was greater than 0.99 in all cases. Keywords : Nateglinide, HPLC assay, method validation
Marmara University