Abstract

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF OPIPRAMOL HYDROCHLORIDE AS BULK DRUG AND IN TABLET DOSAGE FORM

Santosh R. Butle*, Padmanabh B. Deshpande

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 Opipramol Hydrochloride in tablet dosage form. The mobile phase selected was Toluene: Methanol (7: 3, v/v) with UV detection at 256 nm. The retention factor for Opipramol Hydrochloride was found to be 0.45 ± 0.006. The method was validated with respect to linearity, accuracy, precision and robustness as per ICH guidelines. The drugs were subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in the concentration range of 100-600 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 99.56 ± 1.48. The developed method can be used for checking the stability of Opipramol Hydrochloride in bulk drug and pharmaceutical dosage form.

Keywords: Opipramol, HPTLC, Forced degradation, Validation.