Abstract

Stability-indicating spectrophotometricmethods for determination of ceftriaxone in presence of its alkaline degradation product

Author(s): KhalidA.M.Attia,MohammedW.I.Nassar,AbdulAzizM.M.El-Attar

Three simple, sensitive, accurate and precise spectrophotometric methods are used for the determination of Ceftriaxone (CTRX) in presence of its alkaline degradation product (DCTRX),without preliminary separation. The first method is the dual wavelength method, the second is the bivariate method and the third is the Savitzy-Golay filter. The accuracy, precision, and linearity ranges of the proposed methods are determined. The specificity is assessed by analyzing synthetic mixtures containing the drug and its degradate. The methods are validated according to the ICH guidelines and accuracy, precision, repeatability and robustness are found to be within the acceptable limit. The mathematical explanation of the procedures is illustrated. The methods are used for the determination of Ceftriaxone in vials and the obtained results are statistically compared with each other and with the reported method. The comparison showed that there is no significant difference between the proposed methods and the reported method. High lights ï‚· Simple, accurate, selective and precise spectrophotometric methods. ï‚· These methods can be applied for severely overlapped mixtures. ï‚· The limitations and advantages of each aspect were explained. ï‚· These approaches can be applied for the analysis of the dosage form without need for sophisticated instruments or expensive solvents. ï‚· The methods were validated according to ICH guidelines and the parameters were found to be within the limits.