Desenvolvimento de métodos analíticos para avaliação de roxitromicina na forma farmacêutica cápsulas

Abstract

Macrolide antibiotics are a very safe group of antimicrobials, extremely useful against Mycoplasma, Chlamydia, Legionella, Bordetella and other important pathogens. The commercialization of the macrolide antibiotic roxithromycin is authorized by the Brazilian health regulatory agency ANVISA. However, currently no pharmaceutical company makes this drug available on the Brazilian market, and roxithromycin has been commercially available as capsules by compounding pharmacies. The literature reports the development of methodologies for the analysis and quantification of roxithromycin. However, none of them apply to pharmaceutical capsules. In this work, analytical methodologies for the analysis of roxithromycin in the pharmaceutical form capsules were developed and validated: Agar Diffusion Bioassay, using bilayer system and Microccocus luteus strains - INCQS 011 as a revealing microorganism; Method by High Performance Liquid Chromatography (HPLC), using liquid chromatograph with UV / Vis detector and C18 type chromatographic column; And dissolution profile using dissolver apparatus, paddle apparatus, rotation of 100 RPM and 900 mL of dissolution medium per vessel. The methods were validated according to the provisions of the Brazilian validation guide. The microbiological method was linear (r = 0.9985), precise (RSD = 1.53%), exact, selective and robust. In the same way, the chromatographic method showed to be linear (r = 0.9995), accurate (RSD = 1.08%), exact (100.85%), selective and robust. The chromatographic method was used in the development and validation of the dissolution profile, which proved to be selective, precise (RSD = 1.96%), robust and accurate. The proposed methods were applied and presented satisfactory results in the quantitative analysis of roxithromycin capsules, in addition to being presented as low cost alternatives and easy to introduce into routine analytical laboratories.