Τίτλος:
Development and validation of a hydrophilic interaction liquid chromatography method for the quantitation of impurities in fixed-dose combination tablets containing rosuvastatin and metformin
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
A hydrophilic interaction liquid chromatography method with diode array detection (HILIC-DAD) was developed and validated for the simultaneous determination of impurities in extended-release fixed-dose combination tablets containing rosuvastatin and metformin in a ratio 1:100. The analytes were separated by hydrophilic interaction liquid chromatography using an XBridge®-HILIC analytical column under isocratic elution. The mobile phase was composed of ammonium formate at 150 mM containing 0.05% diethylamine (pH 8.5)/acetonitrile, 4/96 (v/v) and pumped at a flow rate of 0.5 mL min−1. Method validation was performed according to ICH guidelines. The calibration curves for rosuvastatin, metformin and their seven impurities showed good linearity (r > 0.994) within the calibration ranges tested. The intra- and inter-day R.S.D. values were less than 4.5%, while the relative percentage error Er was less than 2.7% for all compounds. Accelerated stability studies performed under various stress conditions including hydrolysis, oxidation and heat proved the selectivity of the procedure. A run time of less than 25 min for each sample made it possible to analyze a large number of samples per day. The method is the first reported application of HILIC for the analysis of impurities in fixed-dose combination tablets containing rosuvastatin and metformin and it can be used for the quality control of these drugs. © 2018 Elsevier B.V.
Συγγραφείς:
Machairas, G.
Panderi, I.
Geballa-Koukoula, A.
Rozou, S.
Antonopoulos, N.
Charitos, C.
Vonaparti, A.
Λέξεις-κλειδιά:
Calibration; Column chromatography; Controlled drug delivery; Drug dosage; Drug products; Hydrophilicity; Impurities; Liquids; Quality control, HILIC; Metformins; Method development; Method validations; Rosuvastatin, Liquid chromatography, metformin; rosuvastatin, analysis; chemical phenomena; drug contamination; high performance liquid chromatography; tablet; validation study, Chromatography, High Pressure Liquid; Drug Contamination; Hydrophobic and Hydrophilic Interactions; Metformin; Rosuvastatin Calcium; Tablets
DOI:
10.1016/j.talanta.2018.02.068
