• Rama Chandrapur Uma
• N.V. Murali Krishna
• U. Mohan Kumar
• Tammisetty Mounika
• K. Venkata Subbamma

This study presents the development and validation of a robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Bempedoic Acid and Ezetimibe in combined pharmaceutical dosage forms. These two antihyperlipidemic agents are commonly co-administered for the management of elevated LDL cholesterol levels in patients unresponsive to statin therapy. A reliable analytical method is essential to ensure the quality, safety, and efficacy of such fixed-dose combinations. Chromatographic separation was achieved using an ACE C18 column (4.6 × 150 mm, 5.0 µm) with a mobile phase consisting of methanol and 0.1% orthophosphoric acid buffer (pH adjusted to 3.0) in the ratio of 70:30 v/v. The flow rate was maintained at 1.0 mL/min, with UV detection at 240 nm. Both analytes were well resolved, with retention times of 2.34 minutes for Bempedoic Acid and 3.28 minutes for Ezetimibe. The method was validated according to ICH Q2(R1) guidelines, showing excellent specificity with no interference from excipients or impurities. Linearity was observed over a concentration range of 50–250 µg/mL for Bempedoic Acid and 5–25 µg/mL for Ezetimibe, with correlation coefficients (r²) greater than 0.999. Accuracy was within the acceptable range (98–102%), and precision was confirmed by low %RSD values (<2%). Robustness testing under deliberate changes in flow rate and mobile phase composition confirmed method stability. This validated RP-HPLC method is precise, accurate, and suitable for the routine quality control of fixed-dose formulations containing Bempedoic Acid and Ezetimibe.

RP-HPLC, Bempedoic Acid, Ezetimibe, Antihyperlipidemic Agents

"Development and Validation of an RP-HPLC Technique for Quantitative Analysis of Lipid-Lowering Agents in Pharmaceutical Formulations", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 4, page no.n648-n654, April-2025, Available :http://www.jetir.org/papers/JETIR2504D79.pdf

"Development and Validation of an RP-HPLC Technique for Quantitative Analysis of Lipid-Lowering Agents in Pharmaceutical Formulations", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 4, page no. ppn648-n654, April-2025, Available at : http://www.jetir.org/papers/JETIR2504D79.pdf