Development of a UV-Vis method for minoxidil quantification in compounded capsules
DOI:
https://doi.org/10.36560/19520262279Keywords:
Alopecia, UV-Vis spectrophotometry, Analytical validation, Quality control, Compounding pharmacyAbstract
Oral minoxidil has been used as a therapeutic alternative for the treatment of alopecia, particularly androgenetic alopecia. As the drug is administered at low doses, small variations in the active pharmaceutical ingredient content may alter drug exposure and affect its safety and efficacy, making quality control of compounded formulations relevant. This study aimed to develop and evaluate a UV-Vis spectrophotometric method for minoxidil quantification and to apply it to the determination of minoxidil content in compounded capsules obtained from pharmacies in the state of Pernambuco, Brazil. The method showed linearity, selectivity, precision, accuracy, and robustness compatible with the criteria considered in Brazilian Health Regulatory Agency Resolution RDC No. 166/2017. Formulations containing 0.5, 1.0, 1.5, 2.0, and 2.5 mg of minoxidil were evaluated. All formulations met the average weight determination criteria established by the Brazilian Pharmacopoeia. However, assay results showed substantial deviations from the declared content, ranging from 75.48% to 230.44%, with only one formulation meeting the acceptance range of 90% to 110%. The results indicate that mass uniformity alone does not allow assessment of active pharmaceutical ingredient content compliance and reinforce the importance of analytical methods and quality control in the evaluation of compounded medicines.
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