VALIDATION AND FORCED DEGRADATION BY RP-HPLC OF SELEXIPAG DRUG IN BULK AND DOSAGE FORM
AbstractA new simple, specific, accurate and stability-indicating reversed phase `high performance liquid chromatographic (HPLC) method was developed for the determination of Selexipag using a Grace C18 (250mm x 4.6ID, Particle size: 5 micron) a mobile phase consisting of Buffer (pH-7.4): Methanol 60:40, at a flow rate of 1.0 mL/min and ultraviolet detection at 294 nm. The retention times of Selexipag was found to be 4.296 min. Linearity was established for Selexipag in the range of 20-100 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 of the content of Selexipag in Pharmaceutical dosage form. The method is validated as per ICH guidelines.
Article Information
40
2517-2522
620 KB
485
English
IJPSR
Saloni Borade * and J. Bhangale Charushila
Department of Quality Assurance Techniques, PRES’s, Womens College of Pharmacy, Chincholi, Nashik, Maharashtra, India.
saloniborade321@gmail.com
09 August 202
03 July 2024
06 July 2024
10.13040/IJPSR.0975-8232.15(8).2517-22
01 August 2024
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