RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ARTEMETHER AND LUMIFANTRINE IN PURE AND MARKETED FORMULATION
Journal Title: Int J of Pharm Res & Analy - Year 2016, Vol 6, Issue 1
Abstract
ABSTRACT A simple, rapid, precise and accurate reversed phase high performance liquid chromatographic method has been developed for the simultaneous determination of Artemether in combination with Lumefantrine. This method uses a Hypersil ODS C18(4.6×150mm,5μ particle Size) analytical column, a mobile phase of methanol: ammonium acetate buffer pH 3 adjusted with orthophosphoric acid in ratio(65:35 v/v). The instrumental settings are a flow rate of 1.2 ml/min and PDA detector wavelength at 256 nm. The retention times for Artemether and Lumefantrine were 2.8 min and 3.8 min, respectively. The method is validated and shown to be linear. The linearity range for Artemether and Lumefantrine were 10-50μg/ml & 60-300μg/ml respectively. The Percentage recovery for Artemether and Lumefantrine are ranged between 99–102 and 99–102 respectively. The correlation coefficients of Artemether and Lumefantrine were 0.999, and 0.999, respectively. The relative standard deviation for six replicates is always less than 2%. The Statistical analysis proves that the method is suitable for routine analysis of Artemether and Lumefantrine as a bulk drug and in pharmaceutical formulation. Keywords: Artemether, Lumefantrine, RP-HPLC and Validation.
Authors and Affiliations
D. Chinababu* and M. Sreenivasulu
Keywords
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