Analytical method development and validation of Artesunate and Amodiaquine hydrochloride in tablet dosage form by RP-HPLC
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 6
Abstract
A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of Artesunate (ART) and Amodiaquine hydrochloride (AMO) in pharmaceutical dosage form. The column used was inertsil ODS C18 (250*4.6mm,5µ) in isocratic mode, with mobile phase containing phosphate buffer- acetonitrile-methanol (50:30:20) adjusted to pH 5.8 using ortho phosphoric acid was used and injection volume of 20µL, with a flow rate of 1.0ml/min. and effluents were monitored at 208 nm. The retention times of artesunate and amodiaquine hydrochloride were 5.03 min and 2.77 min, respectively. The linearity for Artesunate and Amodiaquine hydrochloride were in the range of 15-35 mcg/ml and 45.9-107.1 mcg/ml respectively with correlation coefficient of r2=0.999 for both.The assay of the proposed method was found to be 98.56% and 99.08%. The recoveries of artesunate and amodiaquine hydrochloride were found to be 99.81% and 99.3%, respectively. The % RSD from reproducibility was found to be <2%. The proposed method was statistically evaluated and can be applied for routine quality control analysis of artesunate and amodiaquine hydrochloride in bulk and in Pharmaceutical dosage form.
Authors and Affiliations
P RajaRao, Nanda Kishore Agarwal
Keywords
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