Oleyl Alcohol: Purity Testing by Reverse Phase HPLC with

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OLEYL ALCOHOL: PURITY TESTING BY REVERSE PHASE HPLC WITH EVAPORATIVE
LIGHT SCATTERING DETECTION
V. Ioffe, M. Kaadan, A. Rosenberger
Analytical Development, Global Innovative R&D,
Teva Pharmaceutical Industries, Ltd., Israel
RP HPLC method for testing Oleyl alcohol, especially for the precise quantitation of the most
critical impurity – its trans-isomer (Elaidyl alcohol) has been developed. The method comprises
a polymeric RP chromatographic column with medium-chain modifier, free of influence of
residual silanols, and a completely volatile mobile phase, comprising three solvents (water,
acetonitrile and methanol). Optimization of the mobile phase composition to achieve baseline
separation between cis- and trans-isomers, especially when the minor component is eluted after
the major one, is discussed in terms of mechanism of RP chromatographic separation.
Evaporative light scattering detection (ELSD) is used for the compounds, which do not bear any
chromophore. Issues of quantitation are discussed for the detection methods having non-linear
correlation of concentration and response (peak area).
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