A Validated Chiral HPLC Method for the Enantiomeric separation of Mefloquine

Abstract

A validated direct chiral HPLC method was developed for the separation of enantiomers of Mefloquine. The separation was achieved using chiral PAK IG-3 (250 x 4.6 mm) 3μm column. The mobile phase was composed of 10 mM ammonium acetate and methanol in the ratio of 30: 70, v/v. The flow rate of the mobile phase was set at 0.7 ml/min. The detection wavelength was set at 284 nm with column temperature maintained at 25°C. The retention time of both (+) and (−) enantiomers was found to be 4.59 min and 6.47 min, respectively under a runtime of 10 min. The method was validated as per ICH guidelines. The method was found to be linear over a concentration range of 20–120 μg/ml and 15–105 μg/ml for (+) and (−) Mefloquine enantiomers, respectively. The chiral assay of Mefloquine in a pharmaceutical formulation was performed and the recoveries ranged from 99.3 to 99.9%. The detection limit for the (+) and (−) enantiomers was found to be 5.5 μg/ml and 5μg/ml, respectively.