UPLC Method Development, Validation & Degradation Studies of Motixafortide Tablet dosage forms
Abstract
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (UPLC) method has been developed for the quantitative analysis of Motixafortide in bulk and pharmaceutical dosage form. Chromatographic separation of Motixafortide was achieved on Waters Acquity, by using Agilent Eclipse plus C18 (50x 4.6mm, 2.1µm) column and the mobile phase containing Acetonitrile + 0.1% Formic acid in the ratio of 30:70% v/v. The flow rate was 0.5 ml/min; detection was carried out by absorption at 229nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Motixafortide were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Motixafortide.
Fields of Study & Subjects
Analytical Methods in Pharmaceuticals
Biosimilars and Bioanalytical Methods
Analytical Chemistry and Chromatography
Publication details
- Journal / source
- Journal of Pharmaceutical Sciences
- Publication date
- 10 February 2026
- Language
- EN