Development and Validation of Rapid, Sensitive Rp-Uplc Method for Determination of Related Impurities in Dexrabeprazole Sodium

Abstract

Dexrabeprazole sodium (DEX•Na) is an active pharmaceutical ingredient and used as proton pump inhibitor. A reverse phase (RP) ultra-performance liquid chromatographic (UPLC) method is developed for determination of related impurities in DEX•Na and this method is validated using ICH guideline. This method was developed using BEH C18 (2.1 X 50 mm) 1.7 µm column and gradient program for mobile phase. Mobile phase A contains 99% phosphate buffer of pH ~7.0 and 1% acetonitrile, whereas mobile phase B is the methanol and acetonitrile in 95:5 ratio. The 0.45 mL/min total flow rate, 3.0 µL injection volume, 40°C column oven temperature and 284 nm detection wavelength are used with sampling rate of 5 points per second. The DEX•Na peak is well separated from its known and unknown impurities. The run time of the method is reduced to 10 min, which is ~11 times smaller than methods reported in literature. The method is accurate and precise as well as linear in the range of LOQ to 150% level with respect to specification concentration limit of impurities. The stress conditions to DEX•Na revealed that drug is stable in alkaline medium, while it is sensitive to acidic and oxidative condition. The new method is sensitive, precise, accurate, and rapid; it also qualifies all the criteria of linearity, stability, as well as robustness.