T. Kaleemullah, Mansur Ahmed, H. Sharma
Oct 15, 2011
Citations
0
Influential Citations
2
Citations
Journal
Eurasian Journal of Analytical Chemistry
Abstract
A simple and rapid high performance liquid chromatographic method has been established to quantify the optically active precipitant Di-p-Toluoyl-d-Tartaric acid (DPTTA) at very low level in Escitalopram oxalate drug substance. The method is subsequently validated to prove its suitability, sensitivity and repeatability. The high performance liquid chromatographic (HPLC) method is developed in such a way that to enhances the detection level and minimizes acquisition time by using suitable buffer of 0.02% (v/v) of Orthophosphoric acid pH 3.0±0.5 and Acetonitrile as eluent in isocratic mode. The retention time of DPTTA is about 4.0 min and the total acquisition time was less than 15 min. The optimized method was validated to prove its performance characteristics by demonstrating selectivity, sensitivity (limit of detection and quantification), linearity, precision and accuracy. The experimentally established limit of detection and quantification was found to be 0.040 µg mL -1 and 0.120 µg mL -1 respectively and the overall percent accuracy (recovery) of the samples evaluated at different concentration levels was found to be 99.0, indicating the sensitivity and accuracy of this optimized HPLC method by citing the guideline requirement.