Abstract
High Performance liquid chromatography is an integral analytical tool in assessing drug product stability. A simple, selective, precise, accurate and stability indicating RP-HPLC method was developed and validated for analysis of Tadalafil and Macitentan in synthetic mixture. Chromatographic separation was performed using Phenomex Gemini C18 (25cm×4.6nm, 5μm) Column. The mobile phase consists of (10mM Ammonium Acetate in water and [Methanol: ACN 20: 80% v/v]) (40: 60% v/v). The flow rate was set to be 1.0mL/min. The injection volume was 10.00μL. The detection was carried out at 260nm at column temperature 35°C. The method was validating according to ICH Q2R1 guideline for accuracy, precision, reproducibility, specificity, robustness and detection and quantification limits. Stability testing was performed on Tadalafil and Macitentan and it was found that these degraded sufficiently in all applied chemical and physical conditions. Linearity for Tadalafil and Macitentan was observed 0.4-100μg/mL and 0.1-25μg/mL with correlation coefficient at 0.9999. LOD and LOQ 0.008μg/mL and 0.024μg/mL and 0.001μg/mL and 0.0029μg/mL for Tadalafil and Macitentan respectively. The developed RP-HPLC method was found to be suitable for the determination of both the drugs.
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