Asian Journal of Research in Chemistry

T. Kaleemullah ¹, Hemant Kumar Sharma ¹, Pradeep Rajput ¹, Mansur Ahmed ²

Affiliations
1 APL Research Centre (A Division of Aurobindo Pharma Ltd.), 313, Bachupally, Quthubullapur (M), Hyderabad-500090, IN
2 Dept. of Chemistry, Islamiah College, Vaniyambadi-635752 (Thiruvalluvar University, Vellore), IN

Abstract

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.

Keywords

HPLC, Lactic Acid, Cefuroxime Sodium, Validation and Development.

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