摘要

Simple extractive spectrophotometric and HPLC methods are described for the determination of lumefantrine in pure form and in pharmaceutical formulations. These methods are based on the formation of ion association complexes of the lumefantrine with basic dyes safranin 0 and methylene blue in basic buffer of pH 8. The second method described liquid chromatographic procedure that uses micellar mobile phase containing only Tween-20 and n-butanol, is reported for the determination of method for estimation of lumefantrine dosage form. HPLC separation was performed on a Licrosphere C18 column (250 x 4.6 mm) using Tween-20 and n-butanol phosphate buffer, pH 5.1 (60:20:20 v/v) at a flow rate of 1.0 ml/min at 25 degrees C. The % RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of lumefantrine in bulk samples and its formulations.

  • 出版日期2013