Simultaneous Determination of Artemether and Azithromycin in Suppositories by Reversed Phase HPLC

Abstract

Chromatographic parameter assessments for RP-HPLC-UV method development for the simultaneous analysis of artemether and azithromycin for the pharmaceutical analysis of a rectal coformulation currently under development for the treatment of malaria infected children. Using methanol based mobile phase for the analysis of both artemether and azithromycin provided a more robust method in terms of resolution and peak symmetry. The method validated for suppository used 80% methanol and 20% phosphate buffer 15 mM at pH 9. The UV detection was at 210 nm. The accuracy profiles indicated a method validation between 80–120% for both active pharmaceutical ingredients. The preparation process of the suppository was validated based on theoretical values of artemether and azithromycin present in the formulation; active pharmaceutical ingredients were homogenously distributed within the suppository.

Keywords:

• Artemether
• Azithromycin
• Malaria
• RP-HPLC
• Suppository
• Validation

Acknowledgments

This work was supported in part by the Wellcome Trust Foundation, Wellcome Trust Feasibility Award ref: 085242/Z/08/Z. Piero Olliaro is a staff member of the WHO; the authors alone are responsible for the views expressed in this publication and they do not necessarily represent the decisions, policy or views of the WHO.

Notes

^a Ref.: Zhang et al. 2009 and Feitosa-Felizzola and Chiron 2009.

^b Ref.: Haynes et al. 2005.

^c Ref.: Ghasemi and Saaidpour 2007.