A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PIRACETAM

S. Gokulraj*, D. Rajalingam, N. Gnanasekar, U. Prasanna, K. Ganga, N. Jayapriya

Piracetam, chemically 2-oxo-1-pyrrolidineacetamide, is a cyclic derivative of gamma-aminobutyric acid (GABA) and is the prototypical member of the "racetam" class of nootropic agents. It is widely used for cognitive impairment, cortical myoclonus, vertigo, dyslexia, and as adjunct therapy in ischemic stroke, and is frequently formulated in fixed-dose combinations with agents such as citicoline and mecobalamin. Because piracetam possesses a weak UV chromophore and no distinct electroactive or ionizable centre, its precise quantitation in bulk drug and pharmaceutical dosage forms has driven the development of a wide range of analytical methods. This review comprehensively summarizes the physicochemical properties, pharmacokinetics, pharmacodynamics, adverse effects, drug interactions, pharmacovigilance data, regulatory status, and marketed formulations of piracetam. Emphasis is placed on reported analytical techniques for its estimation in bulk and dosage forms, including RP-HPLC, HPLC, UPLC, UV– Visible spectrophotometry, and HPTLC, along with validation parameters such as accuracy, precision, linearity, specificity, robustness, LOD, and LOQ evaluated in accordance with ICH Q2(R1) guidelines. Comparative evaluation indicates that RP-HPLC remains the most widely accepted and reliable method for routine quality control and stability-indicating assays, while UV spectrophotometry offers a rapid, economical alternative and emerging HPTLC/green analytical approaches provide sustainable options for combination-product analysis.