T. Kaleemullah, Hemant Kumar Sharma, Pradeep Rajput, Mansur Ahmed
T. Kaleemullah1,2* Hemant Kumar Sharma1, Pradeep Rajput1 and Mansur Ahmed2
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
Volume - 3,
Issue - 2,
Year - 2010
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 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.
Cite this article:
T. Kaleemullah, Hemant Kumar Sharma, Pradeep Rajput, Mansur Ahmed. Development and Validation of High Performance Liquid Chromatographic Method for Lactic Acid Determination in Cefuroxime Sodium. Asian J. Research Chem. 3(2): April- June 2010; Page 454-458.