Abstract

STABILITY INDICATING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR QUANTITATIVE ESTIMATION OF REMDESIVIR ORAL SOLUTION DOSAGE FORM

Priya Patil*, Pratibha Daroi, Vijay Kumar M., Sayali Warde, R. Mohan Singh, Smita George and Vaidun Bhaskar

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Abstract

The aim was to develop a simple, accurate, precise, and reproducible Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the quantitative estimation of Remdesivir in oral solution dosage form. The chromatographic Separation was performed on the Inert Sustain C18 (4.6 mm × 100 mm i.e., 3 μm particle size) column, and a mobile phase comprising of 0.1 % Triethylamine in Water (pH 3) adjusted with OPA and Acetonitrile in the ratio of (60:40 v/v) was used. The diluent consisting of water and acetonitrile in the ratio of (60:40 v/v) was used. The flow rate was kept at 1 ml/min and detection was carried out at 245nm on UV. The retention time of Remdesivir was found to be about 4.5 min. The validation parameters such as accuracy, precision, linearity, ruggedness, robustness were used for validating the developed method according to ICH guidelines. The method was linear over a concentration range of 10-90 μg/ml with a regression coefficient of 0.9997. The percentage RSD of every parameter was found within the limit. The stress testing studies were executed to give degradation products by exposing the drugs to hydrolytic, photolytic, oxidative, acid, alkali, and thermal degradation conditions. The acquired data showed that the degradation product successfully separated without any intrusion, which establishes stability-indicating the nature of a developed method. The reliable, simple, precise, accurate, and easy for RP-HPLC method has been successfully developed and validated. The developed method was applied for routine quality control analysis of Remdesivir in oral solution dosage forms.

Keywords: Remdesivir, RP-HPLC, Oral Solution, Method Development, Validation parameters, Force Degradation Studies.