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Analytical Method Development and Validation of Macitentan by RP-HPLC Method
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| Author:
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CHABALA OBIREDDY, CHANDAN R S, BARATH M, ANAND KUMAR TENGLI
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| Abstract:
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Macitentan is an endothelin receptor antagonist authorized for Pulmonary arterial hypertension therapy.
Endothelin is a highly active agent constricting blood vessels that is naturally produced by endothelial cells. By
inhibiting the binding of ET-1 to ET receptors, Macitentan inhibits the ET1-dependent Which increase
the intracellular calcium. Therefore, an accurate, fast, simple and cost-effective RP-HPLC technique for detecting
Macitentan was developed. The RP-HPLC method is developed by using ACN and Acetate buffer 80:20 v/v as
MP, the Flow rate is maintained at 1.5 mL/minute. Detection of Macitentan was performed by using UV detector
at 263nm. By this proposed method RT of Macitentan was identified at 3.1 min. The method was validated
concerning system suitability, linearity, accuracy, precision, robustness and ruggedness according to ICH
guidelines
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| Keyword:
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UV detector, RP-HPLC method, Macitentan, ICH guidelines.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.061
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| Download:
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