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@article{182325,
        author = {Puja S. Gaikwad and Dr.Vikas v. patil and Mr.Pankaj S.Patil. and Mr.Amol R.Pawar},
        title = {Development and validation of RP-HPLC method for estimation of Vonoprazan in bulk drug and formulation},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {2},
        pages = {2007-2014},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=182325},
        abstract = {A simple, precise, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Vonoprazan in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved on a C18 column using a suitable mobile phase consisting of [e.g., acetonitrile and phosphate buffer in a specific ratio, pH adjusted if applicable], at a flow rate of [e.g., 1.0 mL/min]. Detection was carried out at a wavelength of [e.g., 280 nm], and the retention time of Vonoprazan was found to be approximately [e.g., 3.5 minutes].
The method was validated according to ICH Q2(R1) guidelines for parameters such as linearity, accuracy, precision, specificity, robustness, and system suitability. Linearity was observed in the concentration range of [e.g., 1–100 µg/mL], with a correlation coefficient (R²) greater than 0.999. The percentage recovery ranged between [e.g., 98–102%], indicating the accuracy of the method. Intra-day and inter-day precision studies showed %RSD values less than 2%, confirming the reproducibility. The method was found to be specific for Vonoprazan with no interference from formulation excipients.
This validated method can be successfully applied for routine quality control analysis of Vonoprazan in bulk and pharmaceutical formulations.},
        keywords = {HPLC, UV, Analytical Chemistry, Vanoprazon.},
        month = {July},
        }