European Journal of Biomedical and Pharmaceutical Sciences

A NOVEL STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR DETERMINATION OF NORETHISTERONE ACETATE AS BULK DRUG AND IN TABLET DOSAGE FORM

Padmanabh B. Deshpande*, Ankit S. Rathod, Nikita H. Bhadane and Isha P. Bhaleghare

ABSTRACT

A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Norethisterone acetate as bulk drug and in tablet dosage form has been developed and validated. Forced degradation studies were carried out under various stress conditions according to ICH guidelines to demonstrate the stability-indicating capability of the developed HPTLC method. Norethisterone acetate was found susceptible to all the analyzed stress conditions except photolysis. Chromatographic resolution of Norethisterone and its degradation products was achieved by using precoated silica gel 60 F254 aluminium plates as stationary phase and Toluene: Ethyl acetate (7.5: 2.5, v/v) as optimum mobile phase. Densitometric detection was carried out at 242 nm. The retention factor was found to be 0.47 ± 0.05. 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 300-1500 ng band-1. The developed method has been applied successfully for the estimation of drug in tablet dosage form.

Keywords: Norethisterone, HPTLC, Forced degradation, Tablet dosage form.