1APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur (M), Hyderabad-500 090, India
2Dept. of Chemistry, Islamiah College, Vaniyambadi-635752, (Thiruvalluvar University, Vellore), India
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 250mm x 4.6mm, 5μm 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 1.0ml min−1, UV detection was performed at 210nm. 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 ml1 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.
HPLC, Lactic acid, Cefuroxime sodium, Validation and development
