European Journal of Biomedical and Pharmaceutical Sciences

VALIDATED STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DETERMINATION OF ABACAVIR SULPHATE IN TABLET DOSAGE FORM

Aniket B. Ithape, Padmanabh B. Deshpande* and Priyanka Shelke

ABSTRACT

A simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Abacavir Sulphate has been developed and validated as bulk drug and in tablet 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. Abacavir Sulphate was found susceptible to all the analyzed stress conditions except photolysis. Chromatographic resolution of Abacavir sulphate and its degradation products was achieved by using precoated silica gel 60 F254 aluminium plates as stationary phase and Chloroform : Methanol (9.2: 0.8, v/v) as mobile phase. Densitometric detection was carried out at 286 nm. The retention factor was found to be 0.25 ± 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 200-1200 ng band-1. The developed method has been successfully applied for the estimation of drug in capsule dosage form. The proposed method can be used for routine analysis of drug in quality control laboratories and can also be helpful for monitoring the potency during shelf life.

Keywords: Abacavir Sulphate, HPTLC, Validation, Forced degradation, Tablet dosage form.