Validated RP-HPLC Method for Simultaneous Estimation of Tadalafil and Macitentan in Bulk and Dosage Forms
Abstract
Reverse-phase high-performance liquid chromatography is a simple, quick, accurate, sensitive, and reproducible technique for quantitatively analyzing Tadalafil and Macitentan in pharmaceutical dosage form. This method is novel as it allows for the simultaneous quantification of both Tadalafil and Macitentan in a single run, which is not widely reported in existing literature.
Waters Alliance-e2695 was used to perform the chromatographic separation of Tadala-fil and Macitentan using an Agilent Eclipse XDB C18 (150x 4.6mm, 3.5μ) column and a mobile phase that contained acetonitrile: 0.1% TFA in a 50:50% v/v ratio. At room temperature, the flow rate was found to be 1.0 ml/min, and a photodiode array detector was used to monitor the absorp-tion at 301 nm.
For Tadalafil and Macitentan, the theoretical plate count was not less than 2000, and the tailing factor should not exceed 2. All measurements have a percentage relative standard devia-tion of peak areas that is consistently smaller than 2.
The suggested approach was validated in compliance with ICH Q2 (R1) regulations. This method was deemed simple, cost-effective, accurate, precise, and reliable for quantitative analysis of the stability study of Tadalafil and Macitentan. The novelty of this work mainly de-pends on the use of specific mobile phase composition, pH, column type, or detection wavelength that achieves excellent separation and peak resolution within a shorter run time.
This study shows excellent sensitivity with…
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