Stability indicating HPLC method for the determination of Cefdinir in presence of its acid induced degradation products.

Author(s): A.M.Kessiba, M.Abd El Kawy, M.A.Hegazy, A.E.El Gindy

High performance liquid chromatographic technique was proposed for the determination of cefdinir (CEF) in presence of its degradation products. The method was based onHPLC separation of CEF fromits acidic degradation products usingYMC-PackODS-A column at ambient temperature with mobile phase consisting of 10mMsodium dihydrogen phosphate : acetonitrile :methanol (80: 10: 10, by volume, 0.5%triethylamine, pH was adjusted to 4.5 using O-phosphoric acid). Quantification was achieved with UV detection at 285 nm based on relative peak area. The drug was subjected to acid hydrolysis. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 10minuteswith the parent compound CEF eluting at approximately 6.5min. The method was linear over the concentration range of 2–25 µg/ml (r2 = 0.9998) with a limit of detection and quantitation 0.0598 and 0.1813 µg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay CEF in capsules and suspension.

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