Abstract

STABILITY INDICATING SIMULTANEOUS ESTIMATION OF ANTIHYPERLIPIDAEMIC DRUGS FROM ORAL THIN FILM PREPARATIONS BY RP-HPLC

Shirish S. Deshpande*, S.Ellur Pavan Kumar

ABSTRACT

The present work deals with an successful RP-HPLC method development for the Simultaneous estimation of antihyperlipidaemic drugs from Oral Thin Film (0TF) preparations.The method developed is found to be Simple, specific,linear,accurate and stability indicating. Chromatographic separation achieved by applying gradient program which is an key parameter to achieve specifity especially. Phenomenax C-18 Column (10 cm X 4.8 mm i.d, 5μm or equivalent) with a mobile phase composed of Methanol:Water (80:20), Rt of Ezetimibe and Simvastatin found to be 11.94 and 14.89 minute respectively. Linearity of method found to be in the range of 20-100 μg/ml. Percentage drug loading in OTF found to be 24.36% from drug estimation studies. Method also complies all the validation parameters as per ICH guidelines. Thus method can be applied for Simultaneous estimation of Simvastatin and Ezetimibe in Oral Thin Film preparations.

Keywords: Simvastatin, Ezetimibe, Oral Thin Film (OTF), RP-HPLC (Reversed Phase High Performance Liquid Chromatography), ICH (International Conference on Hormonization), Rt-Retention time.