การประเมินความจำเพาะของวิธีวิเคราะห์ตามเภสัชตำรับของยา Dihydroartemisinin

Abstract

Dihydroartemisinin (DHA) is an Artemisinin derivative used in combination with Piperaquine as antimalarial regimen which is actively used in Eastern Thailand, Cambodia, and Vietnam. Based on several labile functional groups on DHA structure, such as peroxide and hemiacetal, the drug has been reported to have stability problem and can be degraded via many pathways. A suitable stability indicating analytical method is essential to control the drug quality and it is one of the key for substandard and counterfeit drugs prevention. The DHA monograph in International Pharmacopoeia 2011 has been used primarily to assess the content and purity of DHA through simple isocratic RP-HPLC analysis. However, the specificity of the official method may not be sufficient considering that DHA is highly unstable. In this study, the specificity of method has been verified through series of stress test study. Stress conditions have been used to force the degradation of DHA in order to determine the capability of the method to separate active drug and its related compounds. The results from stress testing in acid and base indicate that the drug monograph issued in International Pharmacopoeia do not have sufficient specificity and require further development.