A Novel Analytical Method for the Estimation of Solriamfetol in Plasma Samples by Lc-Ms/Ms

Abstract

Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor with wake‐promoting effects. The aim of the present  study is to develop a rapid, sensitive and reliable method for the estimation of Solriamfetol in plasma samples using LC-MS.    In the  present  investigation,  a  rapid,  specific,  selective  and  novel  method  has  been  optimized  for  evaluation  of solriamfetol in in plasma using modafinil as an internal standard and identification of degradants by LC-MS/MS. The solriamfetol and internal standard were extracted  from plasma in a single step using acetonitrile. The principle analytes were eluted with the conditions  of  mobile  phase having the  5mM ammonium  format  in methanol:  50% Methanol  in acetonitrile  (90:10%, v/v). The Chromatographic column used is Xterra  MS C18, 3.5µ.m, 1mmX150mm analytical column with the 0.5 ml/min flow rate. The detector is CEM array detector.  The retention times of solriamfetol and modafinil were 1.50min-1.51min with a total run time of 3 min. The curve indicates correlation coefficient (r2) for modafinil was superior by having the value 1.000 with linear range of 5ng/ml  to  500ng/ml.  The  correlation  coefficient  (r2) for  solriamfetol  was found to  be  0.999. The  LOQ  and  LOD  for  the solriamfetol was 33.70pg/ml  and 11.12pg/ml respectively  The developed  method  was validated by evaluating system suitability, selectivity,  sensitivity,  linearity,  precision,  accuracy, ruggedness and stability  in  conformity  with  the  guidelines  of  the  United States Food and Drug Administration  (US-FDA). The results of validation parameters  were found to be within the acceptance limits. Hence,  the  developed and validated method  can be utilized for  the  routine determination of solriamfetol in  plasma samples.