= 0.99) with satisfactory trueness (recoveries between 101.3% and 102.4%) and high precision (coefficient of variation CV ≤ 1.6%). The LOQ was estimated between 0.0020 and 0.0039 mg/mL. Extraction recovery was also evaluated using penicillin G as a model compound due to its chemical and physicochemical similarity to AMX, yielding a recovery of 97.0% ± 0.1%. Application of the validated method to AMX-loaded gummy tablets confirmed a drug content of 94.7% ± 3.7% of the theoretical value. Stability studies, conducted over 6 months under different storage conditions, revealed a progressive decrease in AMX content within the gummy matrix with more pronounced degradation observed under vacuum at 25°C compared to storage in a dry cabinet at room temperature (RT). Overall, the developed RP-HPLC-UV method proved to be reliable and suitable for routine quality control and stability assessment of AMX-containing gummy tablets, supporting further development of this child-friendly dosage form.
Bonafè et al. (Sun,) studied this question.