Determination of cefuroxime in breast milk by LC–MS/MS using SALLME technique

Abstract

The World Health Organization recommends that infants be exclusively breastfed for the first 6 months. Antibiotics are among the most commonly prescribed drugs for pregnant and lactating women. The vast majority of drugs pass into breast milk, which may create a risk for the infant. In cases where drug exposure may pose a risk, breastfeeding should be discontinued. Therefore, the mother's drug use should be decided by considering the most accurate and recent data. Cefuroxime is a second‐generation cephalosporin antibiotic with a broad spectrum of activity against Gram‐negative and ‐positive microorganisms. In this study, we aimed to develop the LC–MS/MS method using salt‐assisted liquid–liquid micro‐extraction (SALLME) for the determination of cefuroxime in breast milk. The method was validated according to the European Medicines Agency (EMA) guidelines. Cefuroxime and the internal standard cefixime were extracted from plasma by a SALLME technique. The results obtained from the entire validation study are at an acceptable level according to the EMA criteria. The calibration curve of cefuroxime was between 25 and 1000 ng/ml, with correlation coefficients of >0.99. The lower limit of quantitation was 25 ng/ml for cefuroxime. Furthermore, the developed method was applied for the determination of cefuroxime in real patient breast milk.