Stability indicating rp-hplc method development and validation of meropenem and vaborbactam in pharmaceutical dosage form

A simple, novel, rapid, accurate and precise stability indicating RP-HPLC method was developed and validated for simultaneous estimation of meropenem and vaborbactum in pharmaceutical dosage form. Meropenem an antibacterial, and vaborbactam, a beta-lactamase inhibitor are indicated for the treatment of complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria. The drugs in this combination were determined by using o-Phosphoric acid (OPA) buffer: acetonitrile (50:50 V/V) as a solvent. Meropenem and vaborbactum peaks were detected at 2.334 and 3.542 min, respectively. The flow rate was 1 mL min-1 and the effluent was monitored at 260 nm. The developed method was validated for different parameters according to ICH guidelines. Linearity range was adjusted to 25-150 μg mL-1 for both drugs. % RSD values for precision studies were found to be within the limits. The % mean recovery was found to be 98.93 for meropenem and 99.94 for vaborbactum. Degradation studies were conducted and the method separates the drug from its degradation products, hence it can be used as stability indicating method for estimation of both drugs in combined dosage form.