Stability indicating RP-HPLC method for Anti-Malarial drug

ABSTRACT

Artesunate (1) (ART), also called as dihydroartemisinin-12-α-succinate, it is a semisynthetic peroxide-bridged sesquiterpene lactone compound derived from Artemisinin, the bioactive component of the Chinese medicinal herb called Artemisia annua.  An accurate, simple and precise HPLC method was developed and validated for forced degradation studies of drug Artesunate .The column was used C18 column (150X4.6mmX5µm ) column  by isocratic elution. The mobile phase composition consisted of Acetonitrile Water and trifluoroacetic acid (TFA) in the ratio of 55:45:0.1 v/v. The analysis was performed at a 1ml/min flow rate. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and lower limit of quantification (LOQ) were determined according to International Conference for Harmonization ICH Q2 (R1) guidelines.

Keywords: Artesunate, HPLC, Stability, Malaria, Validation