RP-HPLC Method Development and Validation for the simultaneous estimation of Meropenem and Vaborbactam in its pure and Dosage form

Abstract

A robust and optimized chromatographic method for the simultaneous quantification of Meropenem and Vaborbactam was developed using Spurcil C18 Column (250×4.6mm, 5µm) with a flow rate of 1.0 ml/min, ensuring excellent peak separation and resolution. System suitability tests confirmed compliance with essential parameters such as resolution, tailing factor, and plate count, reinforcing the method's reliability. The retention times (RT) for Meropenem and Vaborbactam were 3.090 min and 4.215 min, respectively. Linearity assessments demonstrated strong correlation coefficients (>0.999), validating the accuracy of quantification across a concentration range of 10-50 µg/ml. Precision studies exhibited low %RSD values, confirming reproducibility, while accuracy investigations yielded recovery rates within 98-102%, ensuring method robustness. Further validation was performed to assess ruggedness and robustness, confirming method stability under varying chromatographic conditions, including flow rate and mobile phase composition variations. Despite these modifications, retention times remained consistent, reaffirming reproducibility. The method demonstrated high sensitivity, with limits of detection (LOD) and limits of quantification (LOQ) established at 0.01µg/ml for Meropenem and 0.02µg/ml for Vaborbactam. Intermediate precision studies verified assay reliability across different analytical systems and days, further validating its consistency. In conclusion, the developed HPLC method for Meropenem and Vaborbactam is precise, accurate, linear, sensitive, and robust, making it highly suitable for routine pharmaceutical analysis and quality control applications. Compliance with regulatory standards ensures reliable identification and quantification, providing an efficient and reproducible analytical solution for the quality assurance and validation of Meropenem and Vaborbactam formulations.