Enantiomeric Separation of Tenofovir on an Achiral C_(18) Column by HPLC Using L-Phenylalanine as a Chiral Mobile Phase Additive

摘要

A high-performance liquid chromatographic method for chiral separation of tenofovir enantiomers was developed. The (R) and (S) isomers were separated on intertsil ODS 3V column (150 mm x 4.6 mm i.d., 5 (J.m) at 25degC. The mobile phase contained the complex of Cu(II) with the optical selector L-phenylalanine (L-PheA). Satisfactory results were achieved with the mobile phase consisting of buffer (3 mM of copper sulfate, 1 mM of L-PheA, and 20 mM of ammonium dihydrogen phosphate, pH adjusted to 4.0) and acetonitrile in the ratio of 95:5. The method was validated for linearity, repeatability, LOD, LOQ, and robustness. The solution stability was studied and found to be stable for the period of 7 days.