Research Journal of Pharmacy and Technology

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A Validated Chiral HPLC Method for the Enantiomeric Separation of Mefloquine


Affiliations
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, India
2 Department of Pharmaceutical Chemistry, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, India
     

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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.

Keywords

Mefloquine, Enantiomers, HPLC, Validation, ICH.
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  • A Validated Chiral HPLC Method for the Enantiomeric Separation of Mefloquine

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Authors

S. Jenifer Ashwini
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, India
S. T. Narenderan
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, India
S. N. Meyyanathan
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, India
B. Babu
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, India
B. Gowramma
Department of Pharmaceutical Chemistry, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, Tamil Nadu, India

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.

Keywords


Mefloquine, Enantiomers, HPLC, Validation, ICH.

References