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Dear all,
I am dealing with Methylphenidate for BA/BE study, where
methylphenidate is a racemic mixture used in ADHD (CNS stimulant).Here
only the dextro isomer of methylphenidate is pharmacologically active.
So, further dextro form is selectively dosing, to reduce the dose and
adverse effects.
Now my question is, we are using the formulation (capsule) of only
dextro form for the study. Do we need to use only dex methylphenidate
as our analytical/working standard for the plasma concentrations of
dex methylphenidate.I am facing difficulty in procuring dex
methylphenidate but methylphenidate is easily available.Since we are
going to use LC-MS/MS with short run time, can we use methylphenidate
as working standard for the estimation of dex methylphenidate.If so,
how we can justify this. Did any one worked on this molecule.
I am also looking to out source the analysis part of the molecule, I
appreciate your inputs in this regard.Looking for responses from the
expert team
Thanks in advance
Regards
RajaReddy
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