Development and Validation of stability indicating RP-HPLC Method for estimation of combined Drug Bempedoic acid and Ezetimibe in pharmaceutical dosage form."

A simple, precise, accurate, and stability-indicating Reverse Phase HighPerformance Liquid Chromatographic (RP-HPLC) method was developed and validated forthe simultaneous estimation of Bempedoic acid and Ezetimibe in combined pharmaceuticaldosage form. Bempedoic acid is an ATP-citrate lyase inhibitor, while Ezetimibe is a selectivecholesterol absorption inhibitor; both are widely used in the management of hyperlipidemiaand cardiovascular risk reduction.Chromatographic separation was achieved using a C18 column with a suitable mobile phaseconsisting of a mixture of organic solvent and aqueous buffer in optimized ratio, delivered atan appropriate flow rate under isocratic conditions. Detection was carried out using a UVdetector at a selected wavelength where both drugs showed adequate absorbance. Theretention times of Bempedoic acid and Ezetimibe were found to be well resolved with goodpeak symmetry and resolution.The developed method was validated as per ICH Q2(R1) guidelines for parameters such assystem suitability, specificity, linearity, accuracy, precision, robustness, limit of detectionHigh Technology Letters(LOD), and limit of quantification (LOQ). The method exhibited good linearity over theselected concentration ranges with correlation coefficients (R2) greater than 0.999 for bothdrugs. Recovery studies demonstrated accuracy within acceptable limits (98–102%), and%RSD values for precision studies were found to be less than 2%, indicating highreproducibility. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolyticconditions confirmed that the method is stability-indicating, as degradation products werewell separated from the main drug peaks without interference.Hence, the developed RP-HPLC method is simple, rapid, reliable, and suitable for routinequality control analysis of Bempedoic acid and Ezetimibe in combined tablet dosage forms.