A green analytical method for estimation of letermovir in degradation studies

Abstract

The present established analytical method depicts identification of degradation products of letermovir with the aid of U.P.L.C-M.S/M.S. Letermovir was subjected to hydrolysis, oxidation, photolysis and thermal pressure, according to with I.C.H conditions. The analyte shows degradation in oxidative and photolysis stress conditions. The analyte elution was finished on an intersil ODS column (150 × 4.6 m.m; 5 μ.m) with polar eluent contains water and methanol (20:80%, v/v) in an isocratic elution mode at a flow rate of 0.6m.L/min. The eluents have been monitored through the use of a U.P.L.C-M.S/M.S and linearity range was obtained from 50-500 ng./m.L. The method was found to be stable and precision study was expressed in %R.S.D, ranged from 0.43 to 1.69. The developed method was validated as per I.C.H guidelines. No prior approach became made concerning degradation behavior of letermovir. The multiple reaction monitoring transitions were set at and for Letermovir and Tenofovir disoproxil respectively. The calibration curve was linear over the range of 50-550.00ng/ml with lower limit of quantification validated at 50ng/mL. The inter and intra-day accuracy values were below 15% at all quality control levels. The within run and between run precisions were within 15%, while accuracy ranged from 97.07 to 101.98. The degradation products were characterized by comparing their collision induced dissociation mass spectral data with that of Letermovir and the most possible degradation and fragmentation pathways were identified.