Abstract

STUDIES ON STABILITY AND ANALYSIS OF CEFIXIME TRIHYDRATE AND POTASSIUM CLAVULANATE IN PHARMACEUTICAL DOSAGE FORM

Mittal P. Joshi*, Kanan G. Gamit, Dr. Vijay K. Parmar and Priyank P. Raval

ABSTRACT

The Reversed Phase HPLC method has been developed and validated for the estimation of Cefixime trihydrate and Potassium clavulanate in tablet and suspension dosage form. This method was developed using Phenomenex C18 Column (250 mm×4.6 mm id, 5μm) and 25mM NaH2PO4.2H2O pH 6.5 buffer ( 20:80 v/v) as the mobile phase at 1ml/min flow rate with detection at 220nm. This method was validated as per ICH guideline. The method was linear in the concentration of 50-300 μg/ml for CEF and 31.25-187.50 μg/ml for CLAV with a correlation coefficient of 0.999 each. The LOD and LOQ for CEF were 2.611 μg/ml and 7.915 μg/ml respectively. The LOD and LOQ for CLAV were 1.245μg/ml and 3.775μg/ml respectively.The method successfully separated both the drugs from potential degradation products in stress samples with adequate peak purity establishing specificity and stability indicating nature of the method. Tablet and suspension dosage forms of CEF and CLAV were subjected to thermal and photolytic forced degradation study. Besides, suspension was subjected to alkali, acid, neutral hydrolysis and oxidative forced degradation study. CEF did not show degradation under any specified forced degradation condition. All method validation parameters were within the acceptance criteria as per ICH guideline. The method is deemed to be stability indicating as it separates both the drugs from likely degradation products.

Keywords: Cefixime trihydrate, Potassium clavulanate, Suspension, Tablet, Forced degradation study.