Manish G Author

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Quality by Design Based HPLC Method Development of Macitentan and its Related Compounds in Bulk Drugs

Author(s):

Lakshmi D, Hitesh Kumar P, Praveen M, Venkatesh S, Prakash Reddy TVS, Manish G and Jayachandran J

Macitentan is an oral medication, being used for the treatment of idiopathic pulmonary fibrosis. The present study describes the development of HPLC method and subsequent validation for the analysis of Macitentan, an active pharmaceutical ingredient (API) using a quality by design approach.Analysis of macitentan and its related substances was very interesting and challenging due to co-elution of critical pair 1 (impurity C and unknown impurity) and critical pair 2 (impurity D and macitentan). Objective of this study was to develop a robust high performance liquid chromatographic method for the separation of critical pair 1 and 2. An attempt was made to develop HPLC method using QbD principles. A qualityby-design (QbD) based method development can potentially... view more»

DOI: 10.4172/2325-9604.1000158

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