Stability Indicating RP-HPLC Method for Determination of Remdesivir in Sublingual Tablet Dosage Form

A simple, suitable, rapid, precise and accurate RP-HPLC method was developed and validated for estimation of Remdesivir in sublingual tablets. The chromatographic separation was achieved on Inertsustain C18 (4.6 mm X 100 mm, 3 µm) column and Ammonium acetate buffer (pH 4.0) and Acetonitrile in the ratio of 60:40 % v/v was used as mobile phase at a flow rate of 1 ml/min in isocratic mode. The diluent used was Methanol and Water in the ratio of 50:50 % v/v. The detection was carried out at 245 nm by injecting 10 µl solution. Retention time of Remdesivir was found to be around 7.3 min. The method validation was carried out in accordance with ICH guidelines. The method was found to be linear in the concentration range of 5-100 µg/ml and the Correlation coefficient was found to be 0.9996. Mean percent recovery of Remdesivir sample solutions was found to be 100.19 %. LOD and LOQ values for Remdesivir were 1.08 and 3.26 µg/ml respectively. Forced degradation studies were also conducted by subjecting the drug to stress conditions such as acidic, alkaline, hydrolytic, oxidative and photolytic degradation to establish specificity of the method