Study on chiral separation of three drugs collected pharmacopoeia N-alkyl group by HPLC using chiral mobile phase additive and its mechanism / 中国药学杂志

ABSTRACT

OBJECTIVE: To performe chiral separation of three pharmaceutical racemates collected in Ch. P 2010 containing N-alkyl groups, including verapamil hydrochloride, chlorphenamine maleate, and chloroquine diphosphate by using SBE-β-CD as a mobile-phase additive in an HPLC system. METHODS: The analysis was carried out on an Alltima C18 column. The mobile phase consisted of acetonitrile and a phosphate solution added with SBE-β-CD and NaH2PO4, whose pH value was adjusted to 2.5 by phosphoric acid. The flow rate was set at 0.8 mL · min-1, and the column temperature was 25°C. The UV detection was carried out at 332, 264 and 278 nm, respectively. The effects of different factors on the separation effect were investigated, including CD types (β-CD, HP-β-CD), SBE-β-CD concentration, pH value, oven temperature, and buffer concentration. RESULTS: The established method was able to separate the three racemates and the mechanism had been discussed. CONCLUSION: Three racemates can be separated on C18 column using SBE-β-CD as a chiral mobile phase additive. This method might be applied to separate various types of biologically important enantiomers which have N-alkyl groups in the chemical structure.