부산대학교 도서관

A simple, cost-effective, and stability-indicating first-derivative spectrophotometric technique for quantifying Paliperidone in different pharmaceutical formulations is developed. In this method, the drug shows a maximum dA/d[lambda] at 245 nm. The drug follows Beer-Lambert's law in the concentration range 2.5-70 [micro]g/mL. Various degradation studies for the drug, such as acid hydrolysis, base hydrolysis, thermal, oxidative, and photolytic degradation are performed, and the results thereof are within the acceptable limit. The analytical method validation parameters like linearity, LOD, LOQ, precision, accuracy, etc. are conducted for the method as per the ICH Q2R(1) guideline, and the values are within the allowable range. Hence, for the determination of the Paliperidone quantity in pharmaceutical dosage forms, the developed process is a feasible one. Keywords: paliperidone, derivative spectroscopy, forced degradation.
UDC 543.42.062 Introduction. Paliperidone (PD) (9-hydroxyrisperidone) is a major active risperidone metabolite [1]. The FDA approved it in 2006 for both acute and prolonged therapy of schizophrenia. Chemically, PD is [...]