RP-HPLC Method Development and Validation of Genotoxic Impurity 1-Acetyl-2-imidazolidinone content in Tizanidine Hydrochloride

Tizanidine hydrochloride is widely used as a muscle relaxant as 2-6 mg tablet formulation which content 1-Acetyl-2-imidazolidinone as a genotoxic impurity. In this study, an RP-HPLC method was successfully developed and validated in accordance with regulatory requirements for determining 1-Acetyl-2-imidazolidinone in Tizanidine hydrochloride formulation. The sample preparation method is easy and free of toxic solvents. 215 nm observed as λmaxin scanning. The developed method is strictly linear in the range of 1.04-0.16μg/ml. The method was highly précised and robust. The proposed RP-HPLC method is suitable for both the qualitative and quantitative analysis of 1-Acetyl-2-imidazolidinone in Tizanidine hydrochloride formulations.