European Journal of Biomedical and Pharmaceutical Sciences

STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DETERMINATION OF NORTRIPTYLINE AS BULK DRUG AND IN CAPSULE DOSAGE FORM

Pooja P. Pawar and Padmanabh B. Deshpande*

ABSTRACT

The present work describes development and validation of a new simple, accurate, precise and selective stability- indicating high performance thin layer chromatographic (HPTLC) method for determination of Nortriptyline hydrochloride as bulk drug and in capsule dosage form. As stability testing is major step in the development of new drug as well as formulation, stress degradation studies were carried out according to ICH guidelines. Nortriptyline hydrochloride was found susceptible to all the analyzed stress conditions except photolysis. Chromatographic resolution of Nortriptyline hydrochloride and its degradation products was achieved by using precoated silica gel 60 F254 aluminium plates as stationary phase and Toluene: Methanol (6.5: 3.5, v/v) as optimum mobile phase. Densitometric detection was carried out at 240 nm. The retention factor was found to be 0.62 ± 0.02. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. Results found to be linear in the concentration range of 200-1000 ng band-1. The developed method has been successfully applied for the estimation of drug in capsule dosage form.

Keywords: Nortriptyline, HPTLC, Forced degradation, Capsule dosage form.