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Mecitentan & Tadalafil Tablets Assay Methods FDA

A stability indicating RP-HPLC-DAD method was developed for the simultaneous estimation of tadalafil and macitentan in a synthetic mixture for treating pulmonary arterial hypertension. The method was validated for accuracy, precision, and stability, showing effective degradation of the drugs under various conditions. Results indicated strong linearity and low detection limits, confirming the method's suitability for drug determination.

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274 views1 page

Mecitentan & Tadalafil Tablets Assay Methods FDA

A stability indicating RP-HPLC-DAD method was developed for the simultaneous estimation of tadalafil and macitentan in a synthetic mixture for treating pulmonary arterial hypertension. The method was validated for accuracy, precision, and stability, showing effective degradation of the drugs under various conditions. Results indicated strong linearity and low detection limits, confirming the method's suitability for drug determination.

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Anonymous Chemist
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4/14/25, 9:56 AM Stability Indicating RP-HPLC-DAD method for simultaneous estimation of tadalafil and macitentan in synthetic mixture for

mixture for treatment…

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Ann Pharm Fr. 2024 May;82(3):464-472. doi: 10.1016/j.pharma.2023.10.006. Epub 2023 Oct 20.

Stability Indicating RP-HPLC-DAD method for


simultaneous estimation of tadalafil and macitentan
in synthetic mixture for treatment of pulmonary
arterial hypertension
Dhruvanshi Gol 1 , Amitkumar Vyas 2 , Nilam Visana 2 , Ajay Patel 2 , Sunny Shah 2 , Devang Sheth 3 ,
Sandip Dholakia 3

Affiliations
PMID: 37866638 DOI: 10.1016/j.pharma.2023.10.006

Abstract
Objective: 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.

Material and method: 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.

Results: 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.

Conclusion: The developed RP-HPLC method was found to be suitable for the determination of both
the drugs.

Keywords: Hypertension artérielle pulmonaire; Indicateur de stabilité; Macitentan; Mélange


synthétique; Pulmonary arterial hypertension; Stability indicating; Synthetic mixture; Tadalafil.

Copyright © 2023 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

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