Abstract

DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE QUANTITATIVE DETERMINATION OF BREXPIPRAZOLE DIHYDRATE FORM IN BREXPIPRAZOLE ANHYDROUS FORM BY X-RAY DIFFRACTOMETER

Dr. Amit Gosar, *Mr. Mithun Gharat, Mr. Dnyandev Kadu, Mr. Suyog Narvankar, Ms. Chetana Parange

ABSTRACT

Brexpiprazole anhydrous form possibly may convert into Brexpiprazole dihydrate form and determination of dihydrate form content with accurate result is difficult and Brexpiprazole dihydrate form determination method is not reported in literature hence novel specific and accurate method has been developed for the determination of Brexpiprazole dihydrate form by X-ray crystallography. The method has been developed and validated as per International conference on Harmonization guidelines (Q2R1) and found out specific and accurate in validation. The described method is accurate and validated and successfully applied for the determination of dihydrate form of Brexpiprazole.

Keywords: Polymorphism, XRD, Brexpiprazole, Analytical Method Development, Analytical Method Validation.