Development and validation of a hydrophilic interaction liquid chromatography method for the quantitation of impurities in fixed-dose combination tablets containing rosuvastatin and metformin
| Autor: | Ariadni Geballa-Koukoula, Stavroula Rozou, Irene Panderi, George Machairas, Christos Charitos, Ariadni Vonaparti, Nikolaos Antonopoulos |
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| Rok vydání: | 2018 |
| Předmět: |
Diethylamine
Analyte Chromatography 010405 organic chemistry Calibration curve Hydrophilic interaction chromatography 010401 analytical chemistry 01 natural sciences Metformin 0104 chemical sciences Analytical Chemistry chemistry.chemical_compound chemistry Impurity Ammonium formate medicine Rosuvastatin Rosuvastatin Calcium Drug Contamination Acetonitrile Hydrophobic and Hydrophilic Interactions Chromatography High Pressure Liquid Tablets medicine.drug |
| Zdroj: | Talanta. 183:131-141 |
| ISSN: | 0039-9140 |
| DOI: | 10.1016/j.talanta.2018.02.068 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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