Журнал хроматографии и методов разделения
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Development and Validation of a Liquid Chromatographic Method for the Determination of Cefdinir Residues on Manufacturing Equipment Surfaces

Magda A Akl, Mona A Ahmed and Ahmed Ramadan

The cleaning validation procedure for the manufacturing equipment surfaces of cefdinir 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 mm×4.6 mm×5 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-1. UV detection was made at 254 nm. The detection limit (DL) and quantification limit (QL) were 0.7 and 2.2 μg mL-1, respectively. 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%.