Abstract

STABILITY AND ANALYSIS OF MEROPENEM AND β-LACTAMASE INHIBITORS IN INJECTABLE PREPARATIONS

Vandana P. Dhokiya* and J. B. Dave

Abstract

The aim of present work was to develop and validate a common RPHPLC method that can be employed both for fixed dose combination of Meropenem with Sulbactam or Tazobactam that are vital in the treatment of resistant infections. The objective was to study stability of Meropenem injection in combination with Sulbactam or Tazobactam in aqueous reconstituted solution at room temperature and to study stability of marketed formulation of Meropenem and Sulbactam injection in two intravenous fluids at room temperature. In RP-HPLC method, chromatographic separation was achieved on Phenomenex, Phenyl Hexyl (250×4.6 mm, 5μm) column using Acetonitrile: Phosphate buffer solution pH 3.5 (7.5+92.5, v/v) as the mobile phase with UV detection at 220 nm. Both the drugs were subjected to acidic and alkaline hydrolysis and oxidative stress individually and in combination. RP-HPLC method showed adequate linearity in the concentration range of 0.072-0.168 mg/mL for Meropenem, 0.036-0.084 mg/mL for Sulbactam and 0.018-0.042 mg/mL for Tazobactam. The method successfully separated the Meropenem and Sulbactam or Tazobactam from their potential degradation products formed under stress conditions. Stability of reconstituted aqueous solution of Meropenem and Sulbactam as well as Meropenem and Tazobactam was studied and found good for about 4 h Stability of reconstituted solution of Meropenem and Sulbactam injection in normal saline and 5%dextrose intravenous fluid was also studied. The stability of Meropenem was higher in normal saline than dextrose injection.

Keywords: Meropenem, Sulbactam, Tazobactam, High performance liquid chromatography, Validation, Stability study.