Development of a stability– indicating HPLC method for simultaneous determination of ten related substances in vonoprazan fumarate drug substance

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Abstract

Vonoprazan fumarate is a novel potassium-competitive acid blocker for the treatment of acid-related diseases. In the present study, a simple, fast, and economic reversed-phase liquid chromatography (LC) method was developed for the analysis of ten related substances (raw materials, by-products and degradants) in vonoprazan fumarate. The optimized separation was performed on a Phenomenex Kinetex EVO C18 (250 mm × 4.6 mm, 5.0 μm) column. The mobile phase consisted of (A) 0.03 M sodium phosphate buffer (pH adjusted to 6.5) – methanol – acetonitrile (72:25:3, v/v/v) and (B) 0.03 M sodium phosphate buffer (pH adjusted to 6.5) – acetonitrile (30:70, v/v). Detection of the analytes was conducted at 230 nm using a UV detector. The stability-indicating ability of this method was demonstrated by carrying out forced degradation studies. Vonoprazan underwent significant degradation when subjected to alkaline and oxidative stress conditions, while the drug proved to be stable to acidic, thermal and photolytic degradation. The degradants did not interfere with the detection of vonoprazan fumarate and its impurities. The performance of this method was validated in accordance to the regulatory guidelines recommended by the International Conference on Harmonisation (ICH) and this validation included specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness. The method proposed in this paper could be applied for process development as well as quality assurance of vonoprazan in bulk drug, since no monograph is available in official compendia.

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