QUALITY BY DESIGN IN THE DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD BY ULTRAVIOLET-VISIBLE SPECTROPHOTOMETRY FOR QUANTIFICATION OF HYDROXYCHLOROQUINE SULFATE

• Published in: International journal of pharmaceutical sciences and research Vol. 5; no. 11; p. 4666
• Main Authors: Ferraz, Leslie R M, Santos, Fabiana L A, Ferreira, Pablo A, Maia-Junior, Ricardo T L, Rosa, Talita A, Costa, Salvana P M, Melo, Cybelly M, Rolim, Larissa A, Rolim-Neto, Pedro J
• Format: Journal Article
• Language: English
• Published: 01.11.2014
• ISSN: 0975-8232
• DOI: 10.13040/IJPSR.0975-8232.5(11).4666-76

This work describes the application of Quality by Design in the development, optimization, and validation of an analytical method by absorption spectrophotometry in the ultraviolet-visible region for quantification of hydroxychloroquine (HCQ) sulfate. The method was developed from the sample preparation used in the determination of HCQ in dosage form according to the methodology described by the USP 36. Then, the method optimization was performed using a factorial design 22. The validation was performed according to the instructions recommended by the RE No. 899/03 (ANVISA/BRAZIL). The novel method has the advantages of: use only water as a diluent solution and prepare the sample by direct dilution, making it faster and more economically viable and sustainable, given the concepts of green chemistry. The method was demonstrated as: linear, effective and selective, precise and accurate, and robust for all parameters evaluated. The methodology was adequate to replace the recommended USP 36 because there were no significant differences between the results obtained.