TLC- Densitometric Method for Determination of some Cholesterol Lowering Drugs in Different Combinations

Abstract

Sensitive, selective, precise and economic TLC-Densitometric method has been developed for determination of two binary mixtures containing the antihyperlipidemic Ezetimibe (EZ) in its combination with Atorvastatin calcium (AT) [mixture I] and with Simvastatin (SIM) [mixture II]. In the developed TLC-Densitometric method EZ, AT and SIM were quantitatively separated on 60F 254 silica gel plates using ethyl acetate: hexane: glacial acetic acid (5.5:4.5:0.1 by volume) as a developing system with UV detection at 254 nm. Factors affecting the chromatographic separation have been studied, moreover the method has been validated as per ICH guidelines and it has been successfully applied for determination of the studied drugs in their different dosage forms without interference from excepients. Results obtained by the developed TLC-Densitometric method were statistically compared with those obtained by the reported spectrophotometric method and no significant difference was found between them.