Development And Validation Of A Liquid Chromatographic Method For The Determination Of Cefdinir Residues On Manufacturing Equipment Surfaces | 10262
Journal of Analytical & Bioanalytical Techniques
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arefully designed cleaning validation and its evaluation can ensure that residues of cefdinir will not carry over and cross
contaminate the subsequent product. The aim of this study was to validate simple analytical method for verification of
residual cefdinir in equipments used in the production area and to confirm efficiency of cleaning procedure. The cleaning
validation procedure for the equipment was done using cotton swabs moistened with the extraction solution (900 ml of water
and 3.0 ml phosphoric acid and then adjusting the pH to 7.0?0.05). The HPLC method was validated on a LC system using
Waters (USA) Symmetry ? C18 (250 mmx4.6 mmx5 μm) at 25?C in the presence of a mobile phase composed of acetonitrile: pH
7 buffer (85-15) as at flow rate of 1.0 ml/min and an injection volume of 20 μl over the concentration range 14.5?74.5 μg mL
UV detection was made at 254 nm. The detection limit (DL) and quantification limit (QL) were 0.7 and 2.2 μg mL
The intra-day and inter-day precisions, expressed as relative standard deviation (R.S.D.), were below 2.00%. The recoveries were
98.68, 101 and 102.28% for three concentration levels with an average recovery of 100.65 %.
Magda Ali Akl has completed her Ph.D. at the age of 31 years from Mansoura University, Egypt and postdoctoral studies from Faculty of Science,
Mansoura University, Egypt. She is Professor of Analytical Chemistry, Department of Chemistry, Faculty of Science, Mansoura, University, Mansoura,
Egypt, Head of the Scientific Committee of the Mansoura Univeristy, Nanotechnology Center and member of the Administration Council of Mansoura
Univeristy, Nanotechnology Center. She has published more than 35 papers in reputed journals.
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