Development and Validation of an HPLC-MS/MS Method for the Determination of Remdesivir in Rat Plasma

Abstract

Background: Remdesivir is an excellent drug for the medication of covid-19.So; it is an interesting method to develop a novel and reliable HPLC-MS strategy for establishment of  Remdesivir. Objective: To develop a new rapid and sensitive HPLC-MS/MS method for the estimation of Remdesivirin rat plasma using D4- Remdesivir. Methods: Separation was carried on Inertsil ODS column (150x4.6mm, 3.5µm) using a isocratic elution  with  a buffer containing 1ml of tri ethyl amine in 1Litre of water and the mixture of two components like Buffer and Acetonitrile in the ratio of 50:50 as mobile phase with 1ml/min flow rate at ambient temperature. Results: Analysis was performed within 10 minutes over a good linear concentration range from 1ng/ml to 20ng/ml(r2 = 0.999) for Remdesivir .Precision and recovery study results were within the acceptable limit. Anelectro spray ionization source was used to study Remdesivir. This method has been successfully applied; exploring Remdesivir with its internal standard (D4- Remdesivir) was extracted from rat plasma using liquid-liquid extraction. Conclusion: This paper focuses on the consistent evaluation of key bio-analytical validation parameters, including accuracy, precision, sensitivity, selectivity, and standard curve, quantification limits, range, recovery, and stability. In the case of chromatographic methods used in bio analysis, these validation parameters are defined, along with examples of validation methodology.