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Abstract

STABILITY INDICATING SPECTROPHOTOMETRIC AND CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION OF VIGABATRIN USING ICH GUIDELINES

Vinod V. Anuse*, Prof. Dr. Kalkotawar R. S. and Ganesh A. Ghule

ABSTRACT

Vigabatrin is Anticonvulsant class of drug and works by decreasing abnormal electrical activity in the brain. High-Performance Liquid Chromatography (HPLC) is a special branch of column chromatography in which the mobile phase is forced through the column at high speed. In AUC method Water was used as solvent and detection was done at 240nm-280nm. The stability indicating HPLC method was developed and validated for estimation of Vigabatrin. The mobile phase was consisting of ACN: methanol (95:05) pH3. Detection was done at 285 nm. The method was found to be simple, linear, rapid, accurate, precise, reproducible and robust. The % RSD for all parameters was found less than 2. The result showed that the proposed method was suitable for the accurate, precise and rapid determination of in Vigabatrin its bulk form.

Keywords: Vigabatrin, HPLC, Validation, Method development.


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