Open AccessA Novel Analytical Method for the Estimation of Solriamfetol in Plasma Samples by Lc-Ms/Ms
Author(s) -
Ratnakumari Perina.,
N. Kannappan,
Peter Antony Premkumar
Publication year - 2022
Publication title -
international journal of life science and pharma research
Language(s) - English
Resource type - Journals
ISSN - 2250-0480
DOI - 10.22376/ijpbs/lpr.2021.11.5.l129-138
Subject(s) - chromatography , correlation coefficient , chemistry , modafinil , elution , analyte , methanol , analytical chemistry (journal) , mathematics , pharmacology , medicine , statistics , organic chemistry
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.