Development and Validation of Stability-indicating HPTLC Method for Determination of Rizatriptan as Bulk Drug and in Tablet Dosage Form

Ganesh Sarowar, Padmanabh Desh

Abstract

A new simple, accurate, precise and selective stability- indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for estimation of Rizatriptan in tablet dosage form. The mobile phase selected was Benzene: Methanol (8: 2, v/v) with UV detection at 227 nm. The retention factor for Rizatriptan was found to be 0.50 ± 0.006. The method was validated with respect to linearity, accuracy, precision and robustness as per ICH guidelines. The drug was subjected to stress condition of hydrolysis (acid, base), oxidation and thermal degradation. Results found to be linear in the concentration range of 500-2500 ng band-1. The method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean±S.D.) was found to be 99.78±1.38. The developed method can be used for quantitative determination and checking the stability of Rizatriptan in bulk drug and pharmaceutical dosage form.