"Analytical Method Development and Validation of Antiepileptic Drugs: A Review as per ICH Q2 Guidelines"

Analytical method development and validation are essential to ensure the quality, safety, and efficacy of antiepileptic drugs (AEDs). Due to their narrow therapeutic index, accurate and precise quantification is critical. This review summarizes recent advances in chromatographic and spectrophotometric methods, with emphasis on RP-HPLC techniques validated for major AEDs. Comparative studies show RP-HPLC offers superior sensitivity and specificity over UV methods. Validated methods consistently comply with ICH Q2 (R1/R2) requirements, including accuracy, precision, linearity, LOD, LOQ, and robustness. These methods support quality control, stability studies, and therapeutic drug monitoring, ensuring regulatory compliance and patient safety.