Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RPHPLC METHOD FOR SIMULTANEOUS ESTIMATION OF BEMPEDOIC ACID AND ROSUVASTATIN CALCIUM IN ITS TABLET DOSAGE FORM

Dr. Binal Gohil*, Mrs. Yachita Jokhi, Ms. Niyati Patel

Abstract

For the simultaneous estimation of Bempedoic acid and Rosuvastatin calcium in tablet dosage form, a practical, sensitive RP-HPLC technique has been developed and validated by choosing chromatographic parameters. On an Inertsil ODS C18 (100 x 4.6 ID, 3 μm) with mobile phases containing a mixture of 0.1%TFA in water: ACN (40:60, %v/v), isocratic elution mode was used to separate the drugs Bempedoic acid and Rosuvastatin calcium from their processand degradation- related substances. With a detection wavelength of 220 nm, the flow rate was set to 0.6 mL/minute, and the injection volume was set at 70 μL with a 10-minute run time. The developed method's appropriateness was examined and confirmed in accordance with the ICH (Q2 R2) guidelines for studies on specificity, Linearity, Accuracy, Precision, Detection limit, Quantification limit and Robustness. Drug compounds such as Bempedoic acid and Rosuvastatin calcium were treated to heat, hydrolysis, humidity, peroxide, and photolytic stress conditions to observe the degradation products. Bempedoic acid and Rosuvastatin calcium had retention times of 7.24 minutes and 4.11 minutes, respectively. For Bempedoic acid and Rosuvastatin calcium, linearity was found in the concentration ranges of 180-540 μg/mL and 40-120 µg/mL, respectively. For Bempedoic acid and Rosuvastatin calcium, the percentage recoveries ranged from 99.08-101.5% and 99.37-101.58%, respectively. The method was proven to be useful for determining and validating the presence of Bempedoic acid and Rosuvastatin calcium in tablet dosage form.

Keywords: RP-HPLC, Bempedoic acid, Rosuvastatin calcium.