Combining computational and experimental methods is necessary due to the increasing complexity of antiviral drug discovery and the requirement for robust analytical quality control. Letermovir, a novel antiviral medication primarily authorized for the prevention of CMV infection in immune compromised transplant recipients, exhibits unique pharmacology and structure that necessitate precise analytical characterization. Given its therapeutic significance, there is still a significant unmet need for sophisticated, refined, and validated analytical techniques that can ensure Letermovir\u27s quality, stability, and quantification in biological matrices and medication formulations.
Creation and verification of a reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method for Letermovir measurement in rigorous adherence to ICH Q2(R1) standards. Using a C18 column (250 mm × 4.6 mm, 2.5 µm) in isocratic mode with a mobile phase of acetonitrile and phosphate buffer (60:40 v/v) at a flow rate of 1.0 mL/min and a detection wavelength of 240 nm, the analytical condition was also verified. Important validation metrics like robustness, ruggedness, LOD, LOQ, linearity, accuracy, precision, and specificity were thoroughly assessed.
The outcome of this work provides a validated, reproducible, and efficient HPLC method for the analysis of Letermovir suitable for routine quality control, therapeutic drug monitoring, and stability testing. It also serves as a basis for exploring the multi-target therapeutic interest of Letermovir using computer resources. This twofold analytical-In-Silico approach puts in prospect future interdisciplinary approaches to drug discovery and repurposing
