Journal of Pharmacovigilance

Development and validation of new rp - HPLC method for Ceftibuten in bulk and its pharmaceutical dosage form

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Vara Prasad A, K E V Nagoji and V Girija sastry

YRF: J Pharmacovigilance

Abstract:

A simple, precise, rapid and accurate reverse phase HPLC method has been developed for the determination of Ceftibuten in bulk and its pharmaceutical dosage form. A symmetry C18 (4.6x150 mm, 5 mm, Make: XTerra) or equivalent was used with Photo Diode Array UV-Visible detector. The mobile phase consisting of a mixture of phosphate buffer and acetonitrile HPLC grade (40:60) as the mobile phase at a flow rate 1.0 mL/min, the detection was carried out at 228nm. The retention time of the drug was 2.435 minutes. The method was linear over the concentration range of 10-80 μg/ml. the limit of detection and limit of quantification were 0.11 and 0.34 respectively. The percentage recovery of Ceftibuten was 99.41-100.83%. The validation of method was carried out utilizing ICH guidelines.