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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 5
First page : ( 2304) Last page : ( 2308)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00384.6

A Validated Chiral HPLC Method for the Enantiomeric separation of Mefloquine

Ashwini S. Jenifer1, Narenderan S. T.1, Meyyanathan S. N.1,*, Babu B.1, Gowramma B.2

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

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

*Corresponding Author E-mail: snmeyyanathan@jssuni.edu.in

Online published on 8 August, 2019.

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.

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Keywords

Mefloquine, Enantiomers, HPLC, Validation, ICH.

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