Abstract

DEVELOPMENT OF A NEW, RAPID AND SENSITIVE HPTLCDERIVATIZATION METHOD FOR ESTIMATION OF BRIVARACETAM IN BULK AND PHARMACEUTICAL DOSAGE FORM

Rupal Dubey*

Abstract

Brivaracetam is a racetam derivative of levetiracetam. The official High performance thin layer chromatography (HPTLC) method for Brivaracetam has not been published yet. A new, simple, accurate, and precise high-performance thin-layer chromatographic method has been established for analysis of Brivaracetam in tablet formulations. Standard and sample solutions of Brivaracetam were applied to precoated silica gel G 60 F254 HPTLC plates and the plates were developed with Toluene: methanol: triethylamine in the ratio (4:1:0.5 v/v/v), as mobile phase. Ninhydrin solution was used for derivatization purpose. Ultra-Violet detection was performed densitometrically at 278 nm. The percentage relative standard deviation for precision and accuracy of the method was found to be less than 2%. The retention factor of Brivaracetam was 0.45. The linear range was 1000–6000 ng/spot for Brivaracetam; the correlation coefficient, r2, was 0.9988. The method was validated in accordance with the requirements of International Conference on Harmonization guidelines and was shown to be suitable for quantitative estimation of Brivaracetam. The method was successfully used for determination of the drug in tablets. Tablet excipients did not interfere with the high-performance thin-layer chromatographic analysis.

Keywords: Epilepsy, Brivaracetam, Chromatographic separation, Validation.