Spectral signal processing approaches for selective quantification of the recently FDA approved brand-new combination of Vaborbactam and Meropenem; for conformity assessment of bulk and batch release.

Abstract

Vaborbactam (VBR) and Meropenem (MRP) is a recently approved combination for treatment of complicated urinary tract infection (cUTI). Three different signal processing approaches utilizing UV spectral data has been applied for quality assessment of Vabromere® injection. First, the simplest signal processing method, dual wavelength (DW) was developed, where VBR and MRP were determined at (234.0 & 291.0nm) and (219.5 & 245.5nm), respectively. The second one utilized signal processing through derivatization, where, each drug was determined without any interference. This was achieved at 250.0 & 318.0nm for VBR and MRP, respectively. The third approach is the recently developed algorithm, pure component contribution (PCCA), which efficiently extracts the pure spectrum of each drug and therefore determination is achieved at their λmax with maximum sensitivity and lowest error. The applied methods were found to be linear in the concentration range of 5.00-100.00μg/mL and 5.00-150.00μg/mL, for VBR and MRP, respectively. Minimum solvent consumption and diminished preparation or extraction steps are achieved associated with accurate quantitation of VBR and MRP in bulk powders and injection. The developed methods were successfully compared to a reported HPLC method, where no significant difference was found regarding both accuracy and precision.