Development And Validation Of Chromatographic Method For Estimation Of Artesunate In Api And Pharmaceutical Dosage Form

Research Article
Pancholi H.D., , Dobariya P.V., Ladva B.J., Nayak B.S and Jain S
Artesunate, RP-HPLC, ICH guideline Q2R1.

A simple, specific, precise and accurate chromatographic method for estimation of Artesunate inAPI and Pharmaceutical dosage form was developed by Kromasil C18 column having150 mmlength, 4.6 mm internal diameter, 5μ particle size. Peak was observed inmobile phase consist ofAcetonitrile: 0.1 M Sodium Acetate buffer (Adjusted with OPA, pH 3) in the proportion of 60:40 v/v. The flow rate was 1ml/min. The estimation was carried out at 224 nm. The retention time was found to be 5.3 minfor Artesunate.Linearity was found in range of 1000-6000 mcg/ml(Artesunate).The method was validated as per ICH guideline Q2R1. All validation parameters were found to be within accepted range specified in ICH guideline Q2R1.