@article{3026101,
    title = "Development and validation of a hydrophilic interaction liquid chromatography method for the quantitation of impurities in fixed-dose combination tablets containing rosuvastatin and metformin",
    author = "Machairas, G. and Panderi, I. and Geballa-Koukoula, A. and Rozou, S. and Antonopoulos, N. and Charitos, C. and Vonaparti, A.",
    journal = "TALANTA",
    year = "2018",
    volume = "183",
    pages = "131-141",
    publisher = "Elsevier B.V.",
    issn = "0039-9140",
    doi = "10.1016/j.talanta.2018.02.068",
    keywords = "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",
    abstract = "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."
}