Abstract

DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR THE ESTIMATION OF SELEXIPAG IN BULK AND ITS TABLET DOSAGE FORM

Prajakta G. Bonde*, R. S. Bachhav and Somnath Kalegaonkar

ABSTRACT

The current study reported a novel, straightforward, accurate, and exact development for selexipag using RPHPLC technique estimate. The chromatographic procedure was standardised using INERTSIL ODS 4.6250mm, a mobile phase ratio of 70:30 v/v ACN: 0.1 % OPA buffer pH 3, a flow rate of 1 ml/min, and UV detection at 270 nm. 2.16 minutes was discovered to be the retention time. Selexipag's purity was discovered to be 100.43 %, respectively. The theoretical plates and tailing factor, which are system appropriateness characteristics for selexipag, were discovered to be 2832.72 and 1.17, respectively. The linearity investigation of selexipag was conducted in the concentration range of 100 g-500 g, and correlation coefficient (r2), % recovery, and % RSD were all determined to be in the range of 0.999, 100.19, and 0.999, respectively.

Keywords: Acetonitrile, HPLC, Ortho phosphoric acid buffer, Stress degradation, Selexipag.