An Innovative Bioanalytical Method Development and Validation of Rosuvastatin and Bempedoic Acid in its Pure form by using RP-HPLC

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Background: For the present work newly approved drug combination of Rosuvastatin and Bempedoic acid which is an antihyperlipidemic drugs were used. From the vast literature review it was clear that only one chromatographic method was developed, in contrast, a straightforward, fast, accurate, sensitive, and reverse phase high performance liquid chromatographic bioanalytical technique was created and verified in accordance with USFDA 2018 and ICH M10 2022 requirements. Since the developed method makes use of a volatile buffer, it can be applied to regular quality control analysis in the future by employing hyphenated methodologies. Method: Liquid-liquid extraction method is used to extract analytes from the plasma. The mobile phase was 80:20 acetonitrile: water, pH 3.1 (formic acid). It was pumped into an RP-C18 column at 1.0 ml/min. The detection wavelength was 230 nm for 10 min. Diclofenac sodium is used as the internal standard for this method. Results: Calibration curve was obtained between the range 32 ng/µl- 160 ng/µl with r2 0.9951 and 144 ng/µl- 720 ng/µl with r2 0.999 for Rosuvastatin and Bempedoic acid respectively. The retention time for Rosuvastatin 3.30 min, Bempedoic acid 3.95 min and Diclofenac sodium 5.0 min. For Rosuvastatin and Bempedoic acid, the lower limit of detection was 0.31 ng/µl and 12.73 ng/µl and the corresponding lower limits of quantification were 4.88 ng/µl and 46.28 ng/µl respectively. The stability was performed at room temperature for extracted and unextracted sample. Conclusion: The study comprehensively introduces a novel bioanalytical work for identification of Rosuvastatin and Bempedoic acid combination because no specialized UV works or bioanalytical research works in this combination of drug. Therefore, the established approach can be used for pharmacokinetic studies in real clinical samples because it sets up for the quantification of both medications from plasma.

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