Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ALBENDAZOLE

Amrapali M. Pawar* and Prof. Dr. Sunil K. Mahajan

Abstract

Albendazole belongs to the benzimidazole class of Anthelmintic. The present study describes degradation of Albendazole under ICH [Q1A (R2)] prescribed stress conditions (hydrolysis, oxidation, dry heat, wet heat and photolysis) and establishment of a stability-indicating HPTLC method. Different degradation products were observed for Albendazole when each was exposed to different stress conditions. For HPTLC, aluminium plate precoated with Silica Gel 60 F254 and mobile phase consisting of toluene: methanol: ammonia 8: 2: 0.5 v/v/v was used to achieve separation. Quantitation was done at 244 nm. The retention factor for albendazole is 0.41. The method exhibited good linearity (r2>0.998) over the studied range of 200-700 ng/band. The method was validated as per ICH Q2 R1 guidelines and results were in limit. This method was found to be simple, specific, precise and stability indicating.

Keywords: Albendazole, HPTLC, Stability Indicating Method, Validation.