Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND BEMPEDOIC ACID IN TABLETS

Aditi Sharma, Dr. Jaymin G. Patel, Dr. Bhumi R. Patel*, Nima Patel, Janki Patel, Mr. Ronak N. Patel

Abstract

A simple, rapid, economical, precise, and accurate stabilityindicating RP-HPLC method has been developed for the simultaneous estimation of Rosuvastatin Calcium and Bempedoic Acid in tablet dosage form. A reverse phase high performance liquid chromatographic method was developed for the estimation of Rosuvastatin Calcium and Bempedoic Acid in tablets. The separation was achieved using a C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of Buffer (Ammonium Acetate + TFA) and Acetonitrile in the ratio of 55:45, at a flow rate of 1.0 mL/min. Detection was carried out at 220 nm. The retention time for Rosuvastatin Calcium and Bempedoic Acid was found to be approximately 2.729 min and 6.463 min respectively. The method was validated as per ICH guidelines for parameters such as linearity, accuracy, precision, detection limit, and quantitation limit. Linearity was observed over a suitable concentration range for both drugs. The developed method was found to be accurate, precise, and reliable for the estimation of both drugs. The drugs were subjected to various stress conditions such as hydrolysis (acidic and alkaline), oxidation, photolysis, and thermal degradation under the same chromatographic conditions. The degradation products were well separated from the main drug peaks, indicating the stability-indicating nature of the method.

Keywords: Rosuvastatin Calcium, Bempedoic Acid, RP-HPLC, Method Validation, Stability Indicating Method.