Problem:

Endogenous Tretinoin and Isotretinoin are both unstable at ambient temperature and when exposed to light, in addition to being difficult to separate chromatographically. Method development was transferred to KCAS after two other CROs failed to develop a reproducible method that met FDA guidelines (using stripped and artificial plasma).

Proposal:

We proposed using a novel methodology combining both analytes in a single method using authentic matrix.

Outcome:

This previously unpublished approach, using dual HPLC columns and valve switching techniques, permits unknown samples and standard/QC samples to be treated the same way, eliminating systematic error.

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