Validação de metodologia analítica aplicada a adaptação farmacêutica em neonatologia: uma análise comparativa

Abstract

Hydrochlorothiazide (HCTZ) is a thiazide diuretic that has been used to treat bronchopulmonary dysplasia in neonates and, for this, it needs to be adapted to a liquid pharmaceutical form of extemporaneous suspension. Due to the lack of a standardized technique and, consequently, the incr eased possibility of errors in dosing the drug, which could compromise the efficacy and safety of neonatal therapy, it is important to dose this adaptation. Considering that in the Brazilian Pharmacopoeia there is only the UV spectrophotometric method for dosing HCTZ tablets, this work aimed to carry out partial validation by spectrophotometry for dosing pharmaceutical adaptations from HCTZ tablets from different suppliers, as recommended by RDC 166/2017. To this end, selectivity, repeatability and intermed iate precision, and accuracy tests were carried out. Finally, the method proved to be selective (theoretical t < tabulated t), precise (PRD < 5%) and accurate (p > 0.05). In this way, it was possible to develop an analytical method applied to the quality c ontrol of pharmaceutical adaptations, which is important for guaranteeing the quality and safety of these preparations in neonatal intensive care.