European Journal of Biomedical and Pharmaceutical Sciences

STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF ROSUVASTATIN CALCIUM AS BULK DRUG AND IN TABLET DOSAGE FORM

Dipak R Supe, Padmanabh B. Deshpande*, Saurabh Jadhav and Sandeep Swami

ABSTRACT

The present work describes the development and validation of simple, precise and accurate stability indicating high performance thin layer chromatographic method (HPTLC) method for estimation of Rosuvastatin calcium as bulk and in tablet dosage form. Best chromatographic separation was achieved with use of precoated silica gel 60 F254 aluminium plates as stationary phase and mixture of Toluene: Ethyl acetate: Methanol (5: 3: 2, v/v/v) as mobile phase. Densitometric detection was carried out at 242 nm. The drug was subjected to stress conditions of degradation and the method was validated as per ICH guidelines. The developed method shows linearity over a concentration range of 500-2500 ng band-1. The drug was found to be more sensitive towards acidic and thermal stress conditions in comparison to other stress conditions. The proposed method can be effectively applied to accomplish long-term and accelerated stability studies for the determination of rosuvastatin calcium in pharmaceutical formulations.

Keywords: Rosuvastatin calcium, HPTLC, Stability indicating method, Validation.