Please use this identifier to cite or link to this item:
https://www.arca.fiocruz.br/handle/icict/54439
AN INNOVATIVE, SIMPLE, FAST, AND LESS TOXIC HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF PREDNISONE IN CAPSULES
Capsules
High performance liquid chromatography/validation
Linearity assessment.
Author
Affilliation
Department of Pharmaceutical Products. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil,
René Rachou Research Center. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Department of Pharmaceutical Products. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil
Department of Pharmaceutical Products. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil,
René Rachou Research Center. Oswaldo Cruz Foundation. Belo Horizonte, MG, Brazil
Department of Pharmaceutical Products. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil
Department of Pharmaceutical Products. Faculty of Pharmacy. Federal University of Minas Gerais. Belo Horizonte, MG, Brazil,
Abstract
Prednisone is an anti-inflammatory steroid drug widely used in clinical practice. However, no high-performance liquid chromatographic (HPLC) method has been described in the literature for the determination of prednisone in capsules until now. Thus, an HPLC method was developed using a C18 (250x4.0,5 mu m) column, with methanol: water (70: 30) as mobile phase at a flow rate of 1 mL/min and detection at 240 nm. The developed method was validated following current Brazilian legislation. Additionally, linearity was assessed by evaluating the assumptions of normality, homoscedasticity, and independency of residuals, and the fit to the linear model. The method showed linearity (r(2)> 0.99) over the range of 14.0-26.0 mu g/mL, selectivity, precision (RSD < 2.0%), robustness, and accuracy (average recovery of 100.05%). The chromatographic procedure was applied for assay and uniformity content determination of three different batches of prednisone capsules, showing to be suitable for their quality control.
Keywords
PrednisoneCapsules
High performance liquid chromatography/validation
Linearity assessment.
Share