DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR ESTIMATING MONOMETHYL FUMARATE AND APREMILAST

Swati*

ABSTRACT

For the simultaneous measurement of Apremilast and Monomethyl Fumarate (MMF) in pharmaceutical dosage forms and bulk materials, A reverse-phase high-performance liquid chromatography (RP-HPLC) technique that is quick, precise, and dependable was created and verified. Using a mobile phase made up of acetonitrile and phosphate buffer (pH 3.5, adjusted with orthophosphoric acid) in a 60:40 v/v ratio, given at a flow rate of 1.0 mL/min, chromatographic separation was carried out on a C18 column (250 mm × 4.6 mm, 5 μm particle size). A UV detector tuned at 230 nm was used for detection. With correlation coefficients (R2) over 0.999, the technique demonstrated good linearity for MMF and Apremilast throughout Monomethyl Fumarate (MMF) concentrations ranged from 10 to 100 µg/mL, The concentrations of apremilast varied from 5 to 50 µg/mL. The precision, accuracy, specificity, robustness, and sensitivity of the approach were confirmed by validation in compliance with ICH Q2(R1) recommendations. The quantification limit (LOQ) and limit of detection (LOD) for MMF were found to be 2.57 µg/mL and 0.85 µg/mL, respectively, whereas the LOD and LOQ for Apremilast were 1.27 µg/mL and 0.42 µg/mL, respectively. For routine quality monitoring of Apremilast and Monomethyl Fumarate in bulk drugs and formulated products, this validated RP-HPLC technique is appropriate.

Keywords: A UV detector tuned at 230 nm was used for detection.