Development and Validation of High Performance Liquid Chromatographic Method for Lactic Acid Determination in Cefuroxime Sodium

An accurate, sensitive and rapid high performance liquid chromatographic method has been developed and subsequently validated for the determination of Lactic acid in bulk manufacturing of Cefuroxime sodium. Separation was achieved with 250 mm x 4.6 mm, 5 μm particle size, ODS AQ column. The mobile was a gradient prepared by simple phosphate buffer, pH 2.8±0.05 and methanol at a flow rate of 1.0 ml min^-1, UV detection was performed at 210 nm. The method was validated to confirm selectivity, precision, linearity and accuracy as per ICH guideline 1. Because of its speed and accuracy the detection limit and quantification limit ranging from 3.3 μg ml^-1 and 10.1 μg ml^-1 respectively. Repeatability is good, with a relative standard deviation of 0.8% to 1.2%. This simple, efficient methodology can be used for quality control bulk manufacturing as well as routine analysis.