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Development of analytical method for estimation of tadalafil and macitentan by hplc

Dr. Sachin H. Rohane*

Zenodo (CERN European Organization for Nuclear Research), 2026

Abstract

The primary goal of this suggested RP-HPLC approach was to develop and validate analytical procedures for the simultaneous quantitative and qualitative determination of Tadalafil and Macitentan in synthetic mixtures. The HPLC procedure was carried out on a C18 column (particle size 250 mm x 4.6 mm, 5 m). The chromatographic separation was accomplished in gradiant mode with a 92:08% v/v, methanol, and water mobile phase. The flow rate was held constant at 1 ml/min, and the wavelength chosen for estimation was 249nm. The suggested analytical method had a retention time of 3.625 min for Tadalafil and 4.675 min for Macitentan. The linearity range for Tadalafil was 2–12 g/mL. The percentage recoveries for Tadalafil and Macitentan were 100.03% and 100.35%, respectively.To summarize, the proposed endeavor might be used successfully for routine quality control analysis of both medications.

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