The present study is a first report on development of a spectrophotometric method for determination of selexipag (used to cure pulmonary arterial hypertension) in bulk and tablet formulation and its validation. The basis of the proposed method is formation of a chromophore (of λ max 600 nm) in presence of acidic ferric chloride by oxidative coupling reaction between selexipag and MBTH (3-methylbenzo-thiazolin-2-one hydrazone) solution. Regression analysis (r > 0.999) shows that the plotted calibration curve exhibits good linearity in the studied range of concentration (5 – 30 μg mL-1). As per the existing guidelines of ICH, various parameters of the method were tested for validation. Low values of R.S.D. (< 2%) were observed indicating that the proposed method is reproducible, accurate and precise.
Comments: 6 Pages. OK
[v1] 2019-05-19 02:34:18
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