Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção Simultaneous determination of sulfamethoxazole and trimethoprim residues on manufacturing equipment surfaces

Abstract

A cleaning validation method was developed and validated, based on swabbing sampling and simultaneous chromatographic determination of sulfamethoxazole (SMX) and trimethoprim (TMP) residues. The method presented limits of detection of 0.06 mg mL-1 for SMX and 0.09 mg mL-1 for TMP. It was considered selective, precise, accurate and robust according to the guidelines from ANVISA, the Brazilian regulatory agency, and International Conference on Harmonization. Mean swab recovery factors of 98.5% for SMX and 97.7% for TMP were obtained for spiked stainless steel plates. The method was successfully applied to the assay of actual swab samples collected from eleven points on an equipment surface.

Keywords

• HPLC
• cleaning validation
• swabbing recovery