Desenvolvimento de Método Indicativo da Estabilidade, Ensaio de Dissolução e Estudo Preliminar da Estabilidade e Citotoxicidade do Ciprofibrato em Formas Farmacêuticas

Abstract

Ciprofibrate is a hypolipidemic drug widely used to treat hypertriglyceridemia. It is commercially available as tablets and capsules, and, nowadays, there are no official monographs regarding the quality control to this drug in its pharmaceutical forms. The present study aimed to develop and validate a stability indicating chromatographic method for quantitative analysis of ciprofibrate in commercial pharmaceutical forms, development of the dissolution test, to evaluate the drug stability under forced degradation, comprising the determination of the photodegradation kinetics and the study of drug cytotoxicity in the presence of the degradation products. The validation of the analytical method was performed according to parameters described in the Official Guides considering the following analytical parameters: specificity, linearity, precision, accuracy and robustness. The method described in this work had demonstrated to be adequate for ciprofibrate determination in tablets and capsules. The dissolution study was conducted by paddle method (50 rpm) at 37 ± 0,5 °C in 900 mL of hydrochloric acid with addition of 1 % sodium lauryl sulfate, and quantification by spectrophotometry in the ultraviolet. The photodegradation kinetics in acetonitrile under UVC light showed a second-order kinetics for the raw material and both dosage forms. The cytotoxicity evaluation indicated that the ciprofibrate sample in the presence of the degradation products obtained under photolysis does not increase its toxic effect when compared to the intact drug. The results demonstrate the importance of this type of study to ensure the safety and efficacy of marketed pharmaceutical products.