Published Paper Details:

The objective of this study was to develop a reliable and accurate RP-HPLC method for the determination of Linezolid content in drug formulations. The method development involved the optimization of various parameters, including the mobile phase composition, column selection, and detection wavelength. The Linezolid drug and its formulation were subjected to RP-HPLC analysis using the developed method. For the validation of the RP-HPLC method, parameters such as linearity, precision, accuracy, specificity, robustness, and system suitability were evaluated. The linearity of the method was determined by analyzing Linezolid standard solutions at different concentrations. Precision was assessed by repeatability and intermediate precision studies. Accuracy was determined by recovery studies conducted at various spiked levels. The developed RP-HPLC method exhibited satisfactory results for all validation parameters. The linearity of the method was excellent over the specified concentration range. Specificity tests demonstrated that the method was selective for Linezolid, without interference from other components. The method showed robustness, as minor variations in the chromatographic conditions did not significantly affect the Linezolid peak. In conclusion, the developed RP-HPLC method proved to be reliable, accurate, and specific for the estimation of Linezolid drug and its formulation. The validation results indicated that the method is suitable for routine analysis of Linezolid samples, ensuring the quality control of Linezolid-based products and compliance with regulatory guidelines.