What is it about?

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.

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Why is it important?

The proposed method is simple and straight forward as there is no need to main complicated conditions (like intricate sample treatment, tiresome liquid-liquid extractions of chromophores, vigilance to maintain critical optimum pH etc) and can be performed without usage of expensive or sophisticated instrumentation. All these advantages help to encourage the proposed method in routine analysis of selexipag (bulk drug and pharmaceutical dosage forms) in quality control laboratories, as alternatives to the HPLC and LCMS/MS methods

Perspectives

The proposed method is simple and straight forward as there is no need to main complicated conditions (like intricate sample treatment, tiresome liquid-liquid extractions of chromophores, vigilance to maintain critical optimum pH etc) and can be performed without usage of expensive or sophisticated instrumentation. All these advantages help to encourage the proposed method in routine analysis of selexipag (bulk drug and pharmaceutical dosage forms) in quality control laboratories, as alternatives to the HPLC and LCMS/MS methods

Prof Ratnakaram Venkata Nadh
GITAM University

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This page is a summary of: Oxidative Coupling: A Tranquil Approach for Determination of Selexipag by Visible Spectrophotometry, Oriental Journal Of Chemistry, December 2018, Oriental Scientific Publishing Company,
DOI: 10.13005/ojc/340656.
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