Determination of three optical isomer impurities in (R,R)-penehyclidine fumarate by reversed phase high performance liquid chromatography with cyclodetrin as a moble phase additive / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a reversed phase high performance liquid chromatography (RP-HPLC) method for the chiral separation and determination of (R,R)-penehyclidine fumarate and its optical isomer impurities. METHODS: The chiral separation was performed on a C18 (4.6 mm × 250 mm, 5 μm) with mobile phase consisting of acetonitrile -0.05 mol · L-1 phosphates buffer (0.015 mol · L-1 β-cyclodextrin, 0.6% triethylamine, pH 2.3) at flow rate of 1.0 mL · min-1. The column temperature was set at 25°C. UV Detection wavelength was set at 206 nm. RESULTS: The limit of detection (LOD) of three optical isomers was 0.09%. The established chiral HPLC method was used for the quality control of (R,R)-penehyclidine fumarate. CONCLUSION: The method can be used to check and control the optical isomer impurities in the chiral drug, (R,R)-penehyclidine fumarate.