Development and validation of a RP-HPLC Method for the Estimation of Remdesivir in Bulk and Pharmaceutical Formulation

Abstract

A simple, reproducible and efficient reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for estimation of the broad-spectrum antiviral prodrug, Remdesivir in raw material and its injection dosage form. Separation was done by using mobile phase consisting of Acetonitrile : 0.1% Triethylamine, TEA (70:30). The separations were carried out on a Column X-Bridge phenyl (150x4.6mm, 3.5µ) at a flow rate of 1 mL/min. The injection volume was 10 µl and the peaks were detected at 235 nm. The linear dynamic response was  found to be in the concentration range of 50µg/mL-300µg/mL and coefficient of correlation was found to be 0.9989. The %RSD value was below 2.0 µg/mL for intraday and interday precision indicated that the method was highly precise. The LOD and LOQ were found to be 6.0 µg/mL and 20 µg/mL respectively which revealed that the method was highly sensitive. The percentage recovery value was higher than 100 %, indicating the accuracy of the method and absence of interference of the excipients present in the formulation. The proposed method was simple, fast, accurate, precise and reproducible and hence can be applied for routine quality control analysis of Remdesivir in bulk and pharmaceutical formulation.