DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF THEOPHYLLINE IN TABLET FORMULATION

Nathuram Kanthale, Padmanabh Deshpande*, Meghna Mokashi

ABSTRACT

A simple, sensitive and accurate stability indicating HPTLC method has been developed and validated for estimation of theophylline as bulk drug and in tablet dosage form. The separation of drug was achieved by spotting drug on precoated silica gel 60 F254 aluminum plates using ethyl acetate: methanol: acetic acid (9:0.5:0.5, v/v/v) as mobile phase with densitometric detection at 271 nm. The retention factor was found to be 0.60 ± 0.003. The drug was subjected to hydrolytic, oxidative, thermal and photolytic stress conditions. The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the concentration range of 250-1500 ng band-1 with high correlation coefficient. The method found to be accurate as results of the recovery studies are close to 100%. The developed method was found to be simple, sensitive, selective, accurate and repeatable and can be adopted for routine analysis of drug in bulk and tablet dosage form.

Keywords: Theophylline, Stress degradation, HPTLC, Validation.