Abstract

A COMPARATIVE DEGRADATION STUDY ON DIFFERENT BRANDS OF PREGABALIN BY UV SPECTROPHOTOMETERY

Juveriya Fatima Siddiqui*, Mehwish Urooj, Syeda Innayatunnisa Adeeba, Syeda Aliya Mahmoodi and Suryya Abedi

ABSTRACT

The objective of this study was to develop the degradation studies of different brands of Pregabalin available in the market. Forced degradation is a process that involves the degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. Different brands available for Pregabalin is the most prescribed anti-convulsant drug in the class of Fibromyalgia Agents and it has proven efficacy in healing neuropathic pain conditions and fibromyalgia, and for the treatment of partial onset seizures in combination with other anticonvulsants. This drug was subjected to different stress conditions as per International Conference on Harmonization guidelines (ICH). An ultraviolet UV spectroscopic method was developed for analysis of the drug in the presence of the degradation products. Distilled water was used as a solvent. The amount of degraded drugs was calculated by taking the absorbance at 396 nm. According to the assay limit of USP specified that the content should not be less than 95% and not more than 105% of labelled amount, In case of effect acidic pH, Maxgalin ER was more stable. But in case of effect of basic pH all brands of Pregabalin were more or less degraded. In addition to heat exposure Pregalin SR 50 and Gabawin 50 were the most degraded, but other brand was stable. It was concluded that only one brand, Pregalin SR 50 showed accepted results among other brands of acidic and heat effect from ranges for all the stresses applied for degradation studies.

Keywords: Pregabalin, anti-convulsant, degradation studies, assay, USP.