Determination of Organic Acid Impurities in Iron Sucrose: Method Development and Validation by HPLC

In this study, to precisely measure organic acid impurities including Malonic acid, Lactic acid, and Acetic acid in Iron sucrose formulations, an HPLC technique was developed and validated. With a Waters X select HSS T3 column, UV absorbance detection at 205nm, mobile phase was pumped at a rate of 0.5mL/min., the impurities were clearly resolved and showed excellent specificity, with retention times of 10.6minutes for Malonic acid, 11.2 minutes for Lactic acid, and 12.2 minutes for Acetic acid among them. For each acid, the linearity was verified over a range of concentrations, with correlation coefficients more than 0.999 for all acids. Recovery for all acids were from 94.5% to 108.6% according to accuracy tests conducted at four concentration levels (between 25 and 150%), and the technique showed good precision with relative standard deviations under 1%. The technique effectively measured acetic and Lactic acid impurities within their respective limits of 0.50% w/w and 1.5% w/w when applied to iron sucrose samples. This validated HPLC method is offered as a reliable analytical tool for quality control in Iron sucrose drug substances. The method exhibited high specificity, system suitability, reproducible and accurate results all of which improve patient safety and regulatory compliance in therapeutic applications.