Development of a Novel Stability Indicating HPLC Method for the Simultaneous estimation of Aztreonam and Avibactam in Dosage Form Using Response Surface Methodology

Abstract

A simple, rapid, precise, and stability-indicating High-Performance Liquid Chromatography (HPLC) method was developed and validated for the simultaneous estimation of Aztreonam and Avibactam in pharmaceutical dosage form. The method development was carried out using Response Surface Methodology (RSM) to optimize critical chromatographic conditions such as mobile phase composition, flow rate, and detection wavelength. Separation was achieved on a C18 column using an optimized mobile phase consisting of a suitable buffer and organic solvent in appropriate proportion, delivered at an optimized flow rate with UV detection. The developed method demonstrated good resolution between Aztreonam and Avibactam with acceptable retention times and peak symmetry. The method was validated in accordance with ICH guidelines for parameters including linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantification (LOQ). Both drugs showed excellent linearity within the selected concentration range with high correlation coefficients. Forced degradation studies under various stress conditions such as acidic,alkaline, oxidative, thermal, and photolytic degradation confirmed the stability-indicating nature of the method, as degradation products did not interfere with the analyte peaks. The optimized method was found to be accurate, precise, and suitable for routine quality control analysis of Aztreonam and Avibactam in combined dosage forms. In conclusion, the proposed HPLC method, optimized using Response Surface Methodology, is reliable, efficient, and capable of simultaneous estimation of Aztreonam and Avibactam, making it highly useful for pharmaceutical analysis and stability studies.