Simultaneous microdetermination of different penicillin antibiotics residues for cross-contamination study in non-penicillin dosage forms

Abstract

Cross-contamination of non-penicillin products with penicillin drugs can initiate life-threatening allergic hypersensitivity reactions, thus, all non-penicillin products should be tested for contamination before sale. This work describes a fast simple HPLC-DAD method for the simultaneous microdetermination of nine penicillin drugs for studying cross contamination of non-penicillin pharmaceutical dosage forms. Separation was done on C18 column with elution using 0.02 M phosphate buffer and methanol delivered in gradient mode and detection at 220 nm using DAD. Separation of all penicillins from non-penicillin drugs and their co-formulated excipients (methyl paraben, propyl paraben, sorbitol and sodium benzoate) with acceptable suitability parameters was obtained. The linearity ranges were within the range of 0.5–100 µg·mL−1 with good accuracy (Er% between −0.24 and 0.21 %) and precision (RSD% between 0.47 and 0.71 %). Good sensitivity was indicated by the obtained low limits of detection (0.1–1 µg·mL−1) for all the studied compounds. Successful application of the developed method in studying cross contamination of different non-penicillin products including salbutamol syrup and respiratory solution, miconazole cream, biperiden tablet, formoterol inhaler capsule and omeprazole capsule with residues of 9 penicillin drugs was performed without interference from all adjuvants. Henceforth, the proposed method can be recommended for the routine quality control to study and determine cross contamination of the non-penicillin facility with trace amounts of any of the studied penicillins with high accuracy and precision.