Abstract

VALIDATION & FORMULATION DEVELOPMENT OF DRUG "EZETIMIBE" SOLUBILITY ENHANCEMENT BY HYDROTROPIC SOLUBILIZATION TECHNIQUE

Megha Sonkar*, Aarti Nandwana and Umesh Atneriya

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Abstract

In the proposed method Ezetimibe estimated by hydrotropic phenomena. The drug Ezetimibe was physically characterized on the beginning of appearance, color and odor. The Melting point of Ezetimibe was found 163-164°C. Enhancement of solubility was more than 60 to 70% for Ezetimibe respectively in mixed hydrotropic solution, 2M Ammonium Acetate: 2M Sod. Citrate (1:1). The enhancement of solubility of Ezetimibe was observed because of the hydrotropic solubilization phenomenon. Linearity of both drugs was established by response ratios of drugs. Ezetimibe showed linearity in the concentration range of 10-50 μg/ml Calibration curve was plotted, absorbance versus concentration using λmax of 244nm. The accuracy of the proposed methods was assessed by recovery studies at three different levels i.e. 80%, 100%, 120%. In conclusion the developed methods were found simple, sensitive and economical for the simultaneous estimation of selected active pharmaceutical ingredients in their tablet formulation. Validation of developed methods was performed according to ICH guidelines. the proposed methods can be successfully applied for determination and dissolution testing of selected drugs in commercial formulation.

Keywords: Hydrotropy, Ezetimibe, Validation, Analysis, Estimation.