ARCHIVES
VOL. 11, ISSUE 3 (2026)
Bio analytical method development and validation of solriamfetol in rat plasma by LCMS/MS
Authors
Dr. M Sreelakshmi, A Naga Chandra sekhar
Abstract
A simple, rapid, sensitive, and reproducible
LC–MS/MS bio analytical method was developed and validated for the quantitative
determination of Solriamfetol in rat plasma using D5-Solriamfetol as the
internal standard. Plasma samples were prepared by protein precipitation with
acetonitrile, followed by chromatographic separation under optimized LC–MS/MS
conditions. The method was validated according to US FDA bio analytical method
validation guidelines by evaluating selectivity, sensitivity, linearity,
precision, accuracy, recovery, matrix effect, and stability. The assay
exhibited excellent linearity over the concentration range of 2–40ng/ml with a
correlation coefficient (R² = 0.9994). The limit of detection (LOD) and lower
limit of quantification (LLOQ) were 0.27ng/ml and 2.7ng/ml, respectively. No
endogenous interference was observed at the retention times of Solriamfetol and
the internal standard. The method demonstrated acceptable precision and
accuracy within the prescribed regulatory limits, with an overall mean
extraction recovery of 98.99% and negligible matrix effects. Stability studies,
including bench-top, auto-sampler, wet extract, and freeze–thaw stability,
confirmed the stability of Solriamfetol under all tested conditions. The
validated LC–MS/MS method proved to be selective, accurate, precise, and
robust, making it suitable for the routine quantitative estimation of Solriamfetol
in rat plasma and its application in pharmacokinetic and other bioanalytical
studies.
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Pages:24-29
How to cite this article:
Dr. M Sreelakshmi, A Naga Chandra sekhar "Bio analytical method development and validation of solriamfetol in rat plasma by LCMS/MS ". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 11, Issue 3, 2026, Pages 24-29
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