Correspondence of captopril disulfide content with sulfur odor in 25 mg captopril tablets from public pharmacies (health clinics) and commercial drugstores

Abstract

Introduction: Captopril (CP) is the drug of choice for the treatment of hypertension. Its degradation leads to the formation of captopril disulfide dimer (DSCP), associated with a strong odor in the drug, which can cause the patient abandonment of treatment. Objective: To determine DCSP, associate the olfactory perception of the sulfur odor given off by the product and carry out the evaluation of the package insert for captopril 25 mg tablets distributed in the public and private sectors. Method: The performance of CP and DSCP determination method of the Brazilian Pharmacopoeia 6 ed was verified by HPLC (DAD). Thirteen products of 25 mg captopril tablets were analyzed, 2 of which came from the public sector from different batches and the same manufacturer: the other 11 came from the private sector from different batches and manufacturers. The samples were analyzed regarding appearance, odor perception, identification, weight determination, CP and DSCP content (by HPLC) and package insert content. Results: Among the 13, the expired drug had 4.4% DSCP; the others were in accordance with the specification. Correspondence of perceptible sulfur odor was established for drugs with DSCP content above 0.5%. Considering the texts on sulfur odor in the package inserts, the findings were: none information (3 products), characteristic odor (2), slight sulfur odor (1), slight sulfur odor without decreasing effectiveness (7). Conclusions: The samples showed satisfactory results for the tests performed. There was a lack of homogeneity in the information in the package inserts about odor of the tablets. The patient’s perception of sulfur odor, even within the tolerated limit of DSCP, can lead to non-acceptance of the drug and consequent non- adherence to the treatment of hypertension, in addition to causing damage to the SUS.