Abstract

VALIDATION OF REPORTED HPLC METHOD FOR THE SIMULTANEOUSDETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN LOW INCOME LABORATORIES

Author(s): MADUAGWU IFUNANYA JULIET, ONYEGBULE AHAMEFULE FELIX AND NGWOKE KENNETH GERALD

Objectives:Methods  used  in  drug  analysis  should  be  simple,  reproducible,  precise,  accurate  and  applicable  in  both  developed  and  underdeveloped  countries.  This  is exceptionally  important  in  Africa  where counterfeitsof lifesavingdrugs  abound.  It  is  therefore  necessary  that  independent  validation  of  published  new  analytical  methods should  be  carried  out  to  establish  reproducibility  and  suitability  in  low  income  countries.Methods: Two  sample  preparation  methods  and  one  high  pressure  liquid chromatography  (HPLC)  method  reported  for  the simultaneousdetermination  of  lumefantrineand  artemeter  in  Coartem®tablets  were  used  to  analyse  two  batches  of  30 Coartem®samples containing 24 tablets each. The analysis was carried out on a BLC-10 HPLC with a Dstar variable C18 (250 × 4.6mm, 5μm) column and UV detector (210 nm, 254 nm).The sample preparation methodsand HPLC conditions were as reported. Result:Quantitative determinations of the individual drug content in the samples were not possible because no linear correlation was obtained for the plot of area versus concentration of thereference standards.  Sample preparation methods are very important in  obtaining  good  chromatograms. Conclusion:The  methods  as  reported  in  those  published  work  may  not  be  effective  methods  for  the  simultaneous  determination  of artemether and lumefantrine in fixed dose combination tablets like Coartem® in low income laboratories.

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