Abstract

Development and validation of a stability-indicatingHPLCmethod for the determination of related Substances of cephradine drug substance

Author(s): RamalingamMurugan, S.Sriman Narayanan

A simple and sensitive reverse phase high-performance liquid chromatographic method, for the determination of related substances of Cephradine drug substance has been developed and validated. The degraded products and the isolated impurities were analysed by RP-HPLC utilizing a Octadecylsilane Column (YMCPackODS-AM150  4.6mm, 5), followed by ultraviolet detection at 220 nm and a mixture ofAcetonitrile, Phosphate buffer 0.02Mused as a mobile phase in a gradient elution. Thismethod was validated in terms of Selectivity, Linearity, Precision, Accuracy, Robustness, Limit of detection (LOD), Limit of quantitation (LOQ). This method has been succefully applied for drug substance of cephradine.