DEVELOPMENT OF VALIDATED STABILITY INDICATING METHOD BY RP-HPLC FOR SIMULTANEOUS ESTIMATION OF MEROPENEM AND VABORBACTAM IN BULK AND PHARMACEUTICAL FORMULATION

Abstract

Objective: To develop a simple, rapid, precise and reproducible liquid chromatographic method for the estimation meropenem (MEP) and vaborbactam (VAB) in bulk and pharmaceutical formulation and study of the stability of the drugs in different stressed conditions. Methods: The chromatographic separation was achieved on a Kromasil C18 column (250 × 4.6 mm) using a mobile phase composition of acetonitrile and 10 mmol phosphate buffer (pH 3.50) in a ratio 30:70 v/v, pumped at a flow rate of 1.0 ml/min with UV detection set at 260 nm. Results: Symmetrical and sharp peaks of MEP and VAB were obtained at retention times of 2.29 and 3.10 min, respectively. The chromatographic method was validated for linearity, limits of detection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in the concentration ranges of 25–150 μg/ml for MEP and VAB. Stability tests done through the exposure of the analytes solution for different stress conditions and the obtained results indicate no interference of degradants with HPLC method. Conclusion: The proposed method has been found to be selective, precise, linear, accurate, and sensitive. The method can be successfully applied to the assay determination of bulk drugs and combined dosage forms for routine analysis.