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Development and Validation of Stability Indicating LC Method to Quantify Captopril in Tablets of Controlled Release
Authors:Hellen Karine Stulzer  Monika Piazzon Tagliari  Gislaine Kuminek  Paulo Renato Oliveira  Charise Dallazen Bertol and Marcos Antonio Segatto Silva
Institution:(1) Laborat?rio de Controle de Qualidade, Departamento de Ci?ncias Farmac?uticas, Universidade Federal de Santa Catarina, Campus Universit?rio Trindade, bloco K, 3? andar, Florian?polis, SC, CEP 88040-900, Brazil
Abstract:An accurate, simple, reproducible, and sensitive liquid chromatographic method was developed and validated for the captopril determination in controlled release tablets. The analyses were performed at room temperature on a reversed-phase Phenomenex Luna C18 column (250 mm × 4.6 mm). The mobile phase was composed of water:methanol (45:55; v/v) pH 2.5, and it was eluted isocratically at a 1.0 mL min−1 flow rate. The method was validated in terms of specificity, linearity, quantification limit, detection limit, accuracy, precision and robustness. The response was linear in the range 0.3–1.5 mg mL−1 (r 2  = 0.9983). The relative standard deviation values for inter-and intra-day precision were 0.77% and 0.50%, respectively. Recoveries ranged between 97.7 and 99.1%. The method was successfully applied for the determination of captopril in the developed formulations.
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