Abstract

STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION FOR SELEXIPAG IN PHARMACEUTICAL DOSAGE FORM

M. S. Aashka Joshi* and Dr. C. N. Patel

Abstract

A new simple, specific, accurate and stability-indicating reversed phase `high performance liquid chromatographic (HPLC) method was developed for the determination of Selexipag using a Hypersil BDS C18 column (150 mm×5.6 mm, 5.0 μm), a mobile phase consisting of Buffer(ph-5.0): Methanol 60:40, at a flow rate of 1.0 mL/min and ultraviolet detection at 296 nm. The retention times of Selexipag was found to be 5.390 min. Linearity was established for Selexipag in the range of 20-60 μg/mL with correlation coefficients >0.999. The percentage recovery of Selexipag was found to be in the range of 100.99-101.06%. Stress testing was carried out to demonstrate specificity of the method. The developed method could separate the potential degradation products from the Selexipag. This proposed method was suitable for analysis the content of Selexipag in Pharmaceutical dosage form. The method is validated as per ICH guidelines.

Keywords: Selexipag, RP-HPLC Estimation, Analytical Method Validation, Stability.