QUANTIFICATION AND METHOD VALIDATION OF DICYCLOHEXYLUREA CONTENT IN FOSAPREPITANT DIMEGLUMINE DRUG SUBSTANCE BY REVERSE PHASE HPLCAbstract
A simple, sensitive, and rapid reverse phase High-Pressure Liquid Chromatography (HPLC) method was developed and validated for the quantification of residual Dicyclohexylurea in Fosaprepitant dimeglumine drug substance at trace level. The method was optimized on Zorbax Eclipse XDB-C8, 250 mm × 4.6 mm, 5µm with column oven temperature maintaining at 35 °C with flow rate at 0.7 ml/min. Mobile Phase was prepared by a mixture of phosphate buffer pH 7.0 (0.68 g of Potassium dihydrogen orthophosphate in 1000 ml of water) and Acetonitrile in the ratio of 53:47 v/v), the injection volume is 20 µl, the detector wavelength is 205 nm. The developed, optimized method was further validated in accordance with ICH, and the method is found to be specific, sensitive, accurate, and precise. The Limit of detection (LOD) and Limit of quantification (LOQ) for dicyclohexylurea are 20 µg/g and 60 µg/g, respectively. The method validation experimental results are discussed in detail in this research paper.
M. V. Kishore, T. Sivarao, K. R. Srinivas, C. V. Satyendranath, V. J. Kumar *, K. S. R. P. Kumar and N. Sreenivas
Analytical Research, APL Research Centre-II Aurobindo Pharma Limited, Sangareddy, Hyderabad, Telangana, India.
10 October 2019
26 March 2020
28 March 2020
01 October 2020