Validated RP-HPLC-UV Method for the Quantitative Analysis and Stability Evaluation of Amoxicillin in Paediatric Gummy...

Area of Science:

• Pharmaceutical Technology
• Analytical Chemistry
• Drug Formulation

Background:

• Pediatric drug formulation faces challenges in palatability, dosing flexibility, and patient acceptance.
• Innovative dosage forms like gummy tablets aim to improve compliance in pediatric patients.
• Accurate quantitative analysis is crucial for ensuring the quality and efficacy of new drug formulations.

Purpose of the Study:

• To develop and validate a reversed-phase high-performance liquid chromatography coupled with ultraviolet detection (RP-HPLC-UV) method for amoxicillin quantification.
• To determine the amoxicillin content in an innovative gummy tablet formulation designed for pediatric use.
• To assess the stability of amoxicillin within the gummy matrix under various storage conditions.

Main Methods:

• A reversed-phase high-performance liquid chromatography coupled with ultraviolet detection (RP-HPLC-UV) method was optimized and validated according to ICH Q2(R1) guidelines.
• Method validation included specificity, linearity, limit of quantification (LOQ), trueness, precision, robustness, and ruggedness.
• Quantitative analysis and stability studies were performed using amoxicillin (AMX) loaded gummy tablets and a blank matrix.

Main Results:

• The RP-HPLC-UV method demonstrated excellent linearity (R² = 0.99) over the concentration range of 0.0039-0.25 mg/mL.
• The method exhibited high precision (CV ≤ 1.6%) and satisfactory trueness (recoveries 101.3%-102.4%), with an LOQ between 0.0020-0.0039 mg/mL.
• Amoxicillin content in gummy tablets was 94.7% ± 3.7% of the theoretical value, with degradation observed over 6 months, particularly under vacuum at 25°C.

Conclusions:

• The developed RP-HPLC-UV method is reliable and suitable for routine quality control of amoxicillin gummy tablets.
• The method effectively supports stability assessment of this child-friendly dosage form.
• Further development of pediatric gummy formulations is supported by the availability of this validated analytical method.