RP-HPLC method development and validation for the estimation of artemisinin in bulk drug
Keywords:
artemisinin, RP-HPLC, ICH guidelines, antimalarial agentAbstract
Artemisinin is a sesquiterpene lactone obtained from sweet wormwood, Artemisia annua, which is used as an antimalarial for the treatment of multi-drug resistant strains of falciparum malaria. It has a role as an antimalarial and a plant metabolite. Several artemisinin derivatives have been developed for clinical use in prevention and treatment of malaria, some of which have been linked to rare instances of acute liver injury. A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of artemisinin in bulk drug. The separation was achieved on Thermo C18 analytical column (250 mm × 4.6 mm i.d., 5.0μm) using 20mM KH2PO4: acetonitrile in the ratio of 15:85v/v (pH adjust with 4.0 with OPA) in the ratio 15:85 v/v as mobile phase and at a flow rate of 1.0 ml/min. Detection was carried out using a UV detector at 303nm. The total chromatographic analysis time per sample was about 15 min with artemisinin eluting at retention time of about 11.254 ± 0.002min. The method was validated for accuracy, precision, specificity, linearity and sensitivity. Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible.
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