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@article{191669,
        author = {Srushti S. Parmar and Dixit K. Solanki and Dr. Ujashkumar A. Shah},
        title = {Analytical Method Development and Validation of Stability Indicating RP-HPLC Method for The Simultaneous Estimation of Pitavastatin Calcium and Ezetimibe in Pharmaceutical Dosage Form},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {8},
        pages = {7587-7594},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=191669},
        abstract = {Hyperlipidemia is a major clinical concern strongly associated with the development of coronary heart disease. Research has shown that combining statins with ezetimibe improves therapeutic outcomes in the management of this condition. This study aims to develop a simple, accurate, and sensitive stability-indicating method for the simultaneous estimation of Pitavastatin and Ezetimibe in pharmaceutical dosage forms. Chromatographic separation was achieved using an Inert Sustain C18 column (250 mm × 4.6 mm, 5 µm particle size) with a mobile phase comprising buffer and acetonitrile (30:70 v/v). Detection was carried out at 235 nm with a flow rate of 1 mL/min. Method validation was performed according to ICH Q2 (R2) guidelines. The method exhibited linearity over concentration ranges of 20–60 µg/mL for Pitavastatin and 50–150 µg/mL for Ezetimibe, yielding correlation coefficients (R²) of 0.9996 and 0.9992, respectively. The developed RP-HPLC method demonstrated excellent accuracy, precision, and reproducibility, with no observed interference from excipients. Additionally, the stability-indicating capability was confirmed, showing specificity without interference from placebo or degradation products. Thus, the method is suitable for routine quality control and stability analysis of Pitavastatin and Ezetimibe in pharmaceutical formulations.},
        keywords = {Ezetimibe, Method Development and Validation, Pitavastatin, RP-HPLC},
        month = {January},
        }