Development and validation of a reversed phase liquid chromatographic method for the determination of three Gliptins and Metformin in the presence of Metformin impurity (1-cyanoguanidine)
Open Access
- 31 December 2013
- journal article
- Published by European Journal of Chemistry in European Journal of Chemistry
- Vol. 4 (4), 444-449
- https://doi.org/10.5155/eurjchem.4.4.444-449.844
Abstract
A simple and precise liquid chromatographic method has been developed and validated for the determination of either sitagliptin (STG), vildagliptin (VLG) or saxagliptin HCL (SXG) and metformin HCL (MET) in the presence of metformin degradation product, 1-cyanoguanidine (CGN). Chromatographic separation was achieved on a Symmetry® cyanide column (150 mm × 4.6 mm, 5 μm). Isocratic elution using a mobile phase of potassium dihydrogen phosphate buffer (pH = 4.6) - acetonitrile (30:70, v:v) at a flow rate of 1 mL/min with UV detection at 210 nm was performed. The LC method was used for the simultaneous determination of STG, VLG, SXG and MET in the ranges of 5-200, 5-200, 0.5-80.0 and 20-800 μg/mL, respectively. The results were statistically compared with the reference method for each drug using one-way analysis of variance (ANOVA). The method developed was satisfactorily applied to the analysis of the pharmaceutical formulations and proved to be specific and accurate for the quality control of the cited drugs in pharmaceutical dosage forms.Keywords
This publication has 14 references indexed in Scilit:
- Quantitative determination of peptide drug in human plasma samples at low pg/ml levels using coupled column liquid chromatography–tandem mass spectrometryJournal of Pharmaceutical and Biomedical Analysis, 2010
- LC–MS–MS Development and Validation for Simultaneous Quantitation of Metformin, Glimepiride and Pioglitazone in Human Plasma and Its Application to a Bioequivalence StudyChromatographia, 2009
- Pharmacokinetics of the Dipeptidyl Peptidase 4 Inhibitor Saxagliptin in Rats, Dogs, and Monkeys and Clinical ProjectionsDrug Metabolism and Disposition, 2009
- A simple and rapid high-performance liquid chromatographic method for the determination of bisoprolol fumarate and hydrochlorothiazide in a tablet dosage formJournal of Pharmaceutical and Biomedical Analysis, 2008
- Simultaneous Determination of Metformin Hydrochloride, Cyanoguanidine and Melamine in Tablets by Mixed-Mode HILICChromatographia, 2008
- Simultaneous determination of metoprolol succinate and amlodipine besylate in pharmaceutical dosage form by HPLCJournal of Pharmaceutical and Biomedical Analysis, 2008
- Determination of sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tandem mass spectrometryJournal of Pharmaceutical and Biomedical Analysis, 2008
- HPLC-UV determination of metformin in human plasma for application in pharmacokinetics and bioequivalence studiesJournal of Pharmaceutical and Biomedical Analysis, 2008
- New approaches with two cyano columns to the separation of acetaminophen, phenylephrine, chlorpheniramine and related compoundsJournal of Chromatography B, 2005
- Determination of benzhexol hydrochloride and ethambutol hydrochloride tablets by liquid chromatographyAnalytica Chimica Acta, 1995