分析および生物分析技術ジャーナル

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Interlaboratory Development and Cross Validation of a Chromatographic Method for Determination of Lumefantrine in Human Plasma-A Proficient Capacity Assessment of Bioanalytical Laboratories in East Africa

Minzi O, Ngaimisi E, Shewiyo DH, Sasi P and Ignace AM

Background: Bioanalytical laboratories in developing countries face many challenges. The objective of this work was to assess the capacity of bioanalytical laboratories in emerging countries in setting and validating analytical methods. An HPLC method for determination of lumefantrine in human plasma was used to assess three medical university laboratories of Tanzania, Uganda and Kenya.
Methodology: Bioanalytical experts from Analytical Clinical Concept, Leidersbach, in Germany (ACC GmbH) developed the HPLC method and assigned the 3 laboratories to set up and validate the method. The laboratories were tasked to determine the concentrations of blinded plasma samples spiked with lumefantrine and had to submit their analysis reports to ACC for evaluation within 6 weeks. Each laboratory was provided with reference standard, internal standard columns and precolumns. Spiked plasma samples were shipped under dry ice from Germany to “Gesellschaft fuer Internationale Zusammenarbeit” (GIZ) local office of each participating country. All other requirements were procured by individual laboratories.
Results: The results from MUHAS Bioanalytical laboratory (Tanzania) Laboratory met the criteria set by ACC laboratory. The results were within the range set by ACC laboratory and most calibration curves had good linearity with coefficient of correlation always > 0.990. The inter-day precision and accuracy (Relative standard deviation=RD of recovery) were always < 15%. The relative deviation of the results obtained compared to assigned concentrations for blinded plasma samples were between -15% and -25%. The Laboratory met the stipulated time line and the obtained validation results were within the range set by the ACC experts. The results from other laboratories were also satisfactory.
Conclusion: The results indicate that with further little infrastructural and technical assistance the capacity of these bioanalytical laboratories in conducting bio-analyses will be more strengthened and can serve as centers for training bioanalytics and running bioequivalence studies in the region.