Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF REMDESIVIR IN API FORM

*Vishwa Patel, Dr. Neha Tiwari and Dr. Kunal Patel

ABSTRACT

A simple, rapid, economical, precise and accurate RP-HPLC method for Remdesivir In its API has been developed. A reverse phase high performance liquid chromatographic method was developed for the Remdesivir in its API Form. The separation was achieved by C18 (250mm x 4.6 mm, 5μ) column and Buffer, pH 5.0: Acetonitrile (30:70) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 253 nm. Retention time of Remdesivir was found to be 4.402 min. The method has been validated for linearity, accuracy and precision. Linearity observed for Remdesivir was 10-30 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Remdesivir in its API Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in alkaline degradation. The proposed method was successfully applied for the simultaneous estimation of Remdesivir in API form.

Keywords: Remdesivir, Stability Indicating RP-HPLC Method, Validation.