Development and Validation of a Stability-Indicating HPLC Method for the Estimation of Artesunate and some known Degradants using Force Degradation Studies
Kazeem, A. Basheeru,Hussein K. Okoro., Liyansan Segun Michael.
Keywords: Artesunate; forced degradation; high performance liquid chromatography; malaria; stability indicating method
Malaria is an acute feverish illness caused by Plasmodium parasites and responsible for 1-3 million deaths per year. Artesunate, a part of the Artemisinin group of drugs, has been found to be among the most effective drug against this parasite A stability indicating method was developed using a reversed phase high performance liquid chromatography (RP-HPLC) to quantify the Active Pharmaceutical Ingredients (API) and its possible degradants. The chromatographic separation was done on a Gemini C18 (100x 4.6mm, 3µm) column. The mobile phase used was mixture of Phosphate buffer (pH 3.0) and acetonitrile in the ratio of 48:60 (v/v) at isocratic mode and detection of the eluents was done using the UV detector at 216nm. The method shows a good linearity in the concentration range of 50-150% for Artesunate and the impurities (Artemisinin, α-arteminol and β- arteminol) with regression co-efficient ranging from 0.9979 to 0.9999. LOD and LOQ for all the analytes had respective ranges of 0.00531- 0.00125 and 0.00377 – 0.134747. Artesunate had LOD and LOQ of 0.04582 and 0.13747 respectively. The Artesunate tablets and raw material were subjected to various stress tests and the tablets were found to be susceptible to acidic, alkaline and oxidation hydrolysis with the formation of degradants. The proposed stability indicating method was accurate, precise, robust, stable, and specific. The developed method was validated in accordance with ICH guidelines and hence can be successfully applied to the determination of Artesunate and its degradation impurities in tablet formulation.