Abstract:
A new simple, sensitive, precise, and accurate high-performance liquid chromatography (HPLC) method of analysis for artemether both as a bulk drug and in capsule formulations was developed and validated. The method employed mobile phase acetonitrile (ACN) and buffer in the ratio 65:35 of pH 6.5 adjusted with tryethylamine. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9996 in the concentration range 250-750 mg/ml. The mean value slope and intercept were 9355.5 and 293.5, respectively. The method was validated for precision, accuracy, and recovery studies. Limit of detection (LOD) and Limit of quantitation (LOQ) for artemether were found to be 21.83-750 mg/ml, respectively. The method has been successfully applied in the analysis of marketed capsule formulations. The presented method was found to be reliable to separate all the degradents from all the stress conditions with resolution of more than 1.5 showing that it is a stability indicating method.
Key words: ART, forced degradation, high-performance liquid chromatography, stability indicating method of artemether.
