DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR CEFTIBUTEN IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM
Journal Title: Int J of Preclin & Pharm Res - Year 2013, Vol 3, Issue 2
Abstract
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. An enable C18G, 250mmX4.6mm i.d, 5µm particle size column was used with photo diode array UV-Visible detector. The mobile phase consisting of a mixture of phosphate buffer pH3.0 and acetonitrile HPLC grade (35:65) 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 10-80µg/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. Keywords: Ceftibuten, RP- HPLC, Development, Validation
Authors and Affiliations
* Vara Prasad A, K. E. V. Nagoji, V. Girija Sastry, Sree Rama Murthy Pyla, N. Sriram
Keywords
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- EP ID EP107049
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