Abstract

Development and validation of a RP-HPLCmethod for the determination of aztreonamand its related impurities in bulk substances

Author(s): RamalingamMurugan, S.Sriman Narayanan

A facile reverse phase high-performance liquid chromatographic method, for the determination of related substances of Aztreonam drug substance has been developed and validated. The degraded products and the isolated impurities were analysed by RP-HPLC utilizing a Octadecylsilane Column (Waters SymmetryC-18, 2504.6mm, 5), followed by ultraviolet detection at 210 nm followed by 254 nm and a mixture of acetonitrile and phosphate buffer 0.02Mwith pH 3.2, used as amobile phase in a gradient elution. This method was validated in terms of Selectivity, Linearity, Precision,Accuracy, Robustness, Limit of detection (LOD), Limit of quantitation (LOQ). This method has been successfully applied for drug substance of Aztreonam.