Abstract

STABILLITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DETERMINATIONS OF METFORMINE HYDROCHLORIDE AND ROSUVASTATINE CALCIUM IN BULK DRUG AND PHARMACEUTICAL SYNTHETIC MIXTURE.

Balaji Dhepe*, Niket Bajare, Vedanti Yambal and Omprakash Bende

ABSTRACT

The present work describe development and validations of new simple, accurate, Precise, and Selective Stabillity – indicating HPTLC method for simultaneous estimations of Metformine hydrochloride and Rosuvstatine calcium in Bulk drug and pharmaceutical synthetic mixture. Chromatographic resolutions of both the drug was achieved by precoated silica gel G60 F254 Plates as stationary phase and mixture consisting benzene: ethyl acetate: Methanol: Glacial acetic acid (6.5:2:1:0.5 v/v/v) as mobile phase. Densitometric evaluations of seprated analytes was carried out at 245 nm. The retention factors were 0.49±0.04 and 0.70±0.07 for Metformine hydrochloride and Rosuvastatine calcium, respectively. The stress degradations studies were carried out under conditions of acid, base, oxidations, Photolysis and thermal degradations to check the stability indicating power of developed method. The developed method validated with respects to linearity, accuracy, precision, LOD, LOQ, Robustness as per ICH Guidelines. Straight-line calibration graphs were obtained in the concentration range 250-1500 ng/band for Metformine hydrochloride and 20-120 ng/band for Rosuvastatine calcium with high correlation coefficient. The % drug content (Mean ± S.D.) was found to be 99.09 ± 1.72 for Metformine hydrochloride and 99.72 ± 1.75 for Rosuvastatine calcium. The developed procedure has been successfully applied for the estimations of drug in combined dosage form. The developed method can be used for the simultaneous quantifications of these drug as bulk and in pharmaceutical synthetic mixture as well as routine analysis in quality control laboratories.

Keywords: Metformine hydrochloride hydrochloride, Rosuvastatine calcium, HPTLC, Stress degradation.