Abstract

Giri Prasad Gorumutchu¹ and Venkata Nadh Ratnakaram²

DOI : http://dx.doi.org/10.13005/ojc/340656

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.

Colorimetry; MBTH; Oxidative Coupling; Selexipag; Validation

[ View HTML Full Text]