Identification, synthesis, isolation, and characterization of formulation related degradation impurity of Cefadroxil Oral suspension.

Cefadroxil is an orally active, first-generation cephalosporin antibiotic utilized in the treatment of bronchitis, pharyngitis, tonsillitis, urinary tract infections, uncomplicated skin infections, bones, and joints (de Marco and Salgado, 2017 [1]). Cefadroxil for oral suspension is formulated as dry powder for oral suspension. After reconstitution during 14 days storage, we observed an unknown impurity at relative retention time (RRT) 1.29 in cefadroxil oral suspension. The observed level of an unknown impurity was greater than 0.1 % in high-performance liquid chromatography (HPLC) analysis. The present work is focused on the identification, synthesis, and characterization of the unknown impurity by employing several sophisticated analytical techniques. Such as High-resolution mass spectroscopy (HRMS), One dimensional (1D) and two dimensional (2D) nuclear magnetic resonance spectroscopy.