Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF PREGABALIN

Dnyaneshwari Sasane, Abhishek Sable, Aarti Pharate*, Dr. Jyoti Tangde

ABSTRACT

The objective of this study was to develop and validate a simple, sensitive, and economical UV-visible spectrophotometric method for the estimation of Pregabalin in bulk drug and pharmaceutical dosage forms. Pregabalin is commonly prescribed for the treatment of neuropathic pain, epilepsy, fibromyalgia, and anxiety disorders, making accurate analytical methods essential for quality assurance. Methanol was selected as the analytical solvent because of its excellent solubility and compatibility with UV analysis. The maximum absorbance of the drug was observed at 207.7 nm, and the method demonstrated a linear response within the concentration range of 10–50 µg/mL. Validation was performed according to ICH Q2 (R1) and Q2 (R2) recommendations by assessing linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. The validation results confirmed that the developed method produced reliable, reproducible, and accurate results within acceptable criteria. The assay of the marketed tablet formulation also confirmed the applicability of the method for pharmaceutical analysis. Due to its simplicity, rapid analysis, and low operating cost, the proposed method is well suited for routine quality control testing of Pregabalin in pharmaceutical laboratories.

Keywords: Pregabalin, UV-Visible Spectrophotometry, Analytical Method Development, Method Validation, ICH Q2(R1), ICH Q2(R2), Linearity, Accuracy, Precision, Robustness, Limit of Detection (LOD), Limit of Quantification (LOD).