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

Developed originally as an antimalarial agent, the hydroxychloroquine sulfate (HCQ) is often used as a slow-acting anti-rheumatic drug in treating disorders of connective tissue. The methods of quantification of HCQ sulfate, despite the undeniable advantages, have certain limitations, such as high cost of operation and maintenance of equipment, sample processing and analysis of the results relatively complicated. However, the simplicity of the process and velocity of the spectrophotometry by absorption in the UV -Vis region corroborate the usefulness of this methodology. This work describes the application of QbD in the development, optimization, and validation of an analytical method by absorption spectrophotometry in the UV-Vis region for quantification of 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 prepares the sample by direct dilution, making it faster and more economically viable and sustainable, given the concepts of green chemistry. The method was demonstrated: 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.