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Abstract: The present study outlines the development and validation of a precise, accurate, and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of Vericiguat, a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of heart failure with reduced ejection fraction. Chromatographic separation was achieved using a Hypersil,C18(250mm x 4.6ID,particle size :5um) column, with a mobile phase composed of MeOH : H2O:TFA, in proportion of 75:25:0.1 respectively, at a flow rate of 1.0 ml/min. Detection was carried out at a wavelength of 257 nm. The method was validated in accordance with ICH and USFDA bioanalytical guidelines, evaluating key parameters such as specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), recovery, and stability. Vericiguat exhibited a retention time of approximately 3.746 minutes. Linearity was established over the concentration range of 10-30ug/ml, yielding a correlation coefficient (R²) of 0.99997. The method demonstrated acceptable intra- and inter-day precision, with relative standard deviation (RSD) values within permissible limits. Recovery studies showed consistent and reproducible results, confirming the efficiency of the extraction process from biological matrices. This validated RP-HPLC method proves to be reliable and suitable for routine bioanalytical applications, including the quantitative estimation of Vericiguat in human plasma and potential use in pharmacokinetic and therapeutic drug monitoring studies.
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Cite Article:
"Bio-Analytical Method Development and Validation
of Antihypertensive Drug by RP HPLC Method", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.10, Issue 7, page no.a291-a299, July-2025, Available :http://www.ijrti.org/papers/IJRTI2507034.pdf
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2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator