METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR DETERMINATION OF ASSAY OF MACITENTAN
Aniket P. Kothawade*, Ashwini V. Shelke and Anil G. Jadhav
ABSTRACT
A simple, correct, defined and specific stability indicating RP-HPLC method was developed and validated for the investigation of Macitentan. The chromatographic separation was done in 6 min by Agilent 1100 Series C18 Column (250mm*4.6mm) hypersil ODS column using Acetonitrile: Methanol: water (90:5:5) as a mobile phase and flow rate is set to 1.2ml/min. 211 nm was selected as a detection wavelength. The retention time of macitentan were found to be 2.68 min. 20 μl sample volume was injected into the column at the maintained temperature of 300C. The present method has been validated for Specificity, Stability, Linearity, Precision, and Robustness. The proposed method was effectively functional for the
quantitative determination of macitentan in the bulk form.
Keywords: Macitentan, RP-HPLC method, Method development, Validation.
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