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ZENODO
Article . 2026
License: CC BY
Data sources: ZENODO
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
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ANALYTICAL METHOD DEVELOPEMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ANTIHYPERLIPIDEMIC COMBINATION BY RP-HPLC METHOD

Authors: 1Dr. Deshpande A. N., *2Ms. Shinde P. S., 3Ms. Chanshetty S. S., 4Ms. Hande A. S.;

ANALYTICAL METHOD DEVELOPEMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ANTIHYPERLIPIDEMIC COMBINATION BY RP-HPLC METHOD

Abstract

A simple, rapid, economical, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Bempedoic acid and Ezetimibe in bulk drug and combined tablet dosage form. Chromatographic separation was achieved using a Kromosil C18 (150 × 4.6 mm, 3.0 µm) column with an isocratic mobile phase consisting of 0.01 N potassium dihydrogen phosphate (KH₂PO₄) buffer and methanol in the ratio of 80:20 v/v, delivered at a flow rate of 0.9 mL/min. The column was maintained at 30 °C, and detection was performed at 229 nm. The retention times of Bempedoic acid and Ezetimibe were found to be 2.132 min and 2.586 min, respectively, indicating a short run time of less than 3 minutes. The method exhibited excellent linearity over the concentration ranges of 22.5–135 µg/mL for Bempedoic acid and 1.25–7.5 µg/mL for Ezetimibe, with correlation coefficients (R²) of 0.9999 for both analytes. Accuracy studies showed mean recoveries of 100.00% for Bempedoic acid and 100.14% for Ezetimibe. Precision, robustness, specificity, and sensitivity parameters complied with ICH Q2(R1) guidelines. LOD/LOQ values were 1.01/3.38 µg/mL for Bempedoic acid and 0.02/0.05 µg/mL for Ezetimibe. Forced degradation studies under acid, base, oxidative, thermal, UV, and water stress conditions confirmed the stability-indicating nature of the method. Overall, the proposed RP-HPLC method is accurate, reliable, reproducible, and suitable for routine quality-control analysis of combined Bempedoic acid and Ezetimibe formulations.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
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