Authors : M. Gandhimathi; Sarath Babu S. V.; Jenaardhanhan A. G.; Sasikumar S.

Volume/Issue : Volume 11 - 2026, Issue 1 - January

Google Scholar : https://tinyurl.com/39znexfk

Scribd : https://tinyurl.com/yc699wyc

DOI : https://doi.org/10.38124/ijisrt/26jan616

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Abstract : Two analytical methods were developed for the determination of vigabatrin in formulation. The first method is visible spectrophotometry based on vigabatrin reaction with ninhydrin reagent in phosphate buffer (pH 7.4) to form a purple-colored chromogen (Ruhemann’s purple) exhibiting maximum absorbance at 572 nm. Derivatization of Vigabatrin was carried out by treating the drug solution with phosphate buffer and ninhydrin reagent and heating for 15 min. The resulting solutions were analysed at 572 nm. The second method is HPTLC of Vigabatrin was achieved using Merck TLC aluminium plates precoated with silica gel G 60 F254.The derivatized samples were applied on the TLC plate, and chromatographic separation was achieved using acetone: chloroform (3:7, v/v) as the mobile phase. The developed chromatogram was scanned densitometrically at 572 nm. The developed methods were validated for linearity, precision, accuracy, LOD, LOQ, and robustness as per ICH Q2(R2) guidelines. The calibration curve was linear over the concentration range of 15–48 ng/band in HPTLC method and 10–50 μg/mL in visible spectroscopic method, with correlation coefficient (r2) > 0.99. The proposed methods were found to be specific, precise, accurate, and robust. Both the methods are economical and successfully applied for the analysis of vigabatrin in tablet dosage form. The amount obtained is as per with label claim of the product. Two methods are first of their kind and shall be applied to the routine quality control analysis of Vigabatrin in formulation.

Keywords : Vigabatrin, Derivatization, Visible, HPLTC, Formulation.

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