Method development and validation for the simultaneous estimation of arterolane maleate and piperaquine phosphate by RP-HPLC in pharmaceutical dosage form

Objective: The aim of this proposed work was to develop and validated to simple, rapid, precise, robust and specific method as per International Conference on Harmonization (ICH) guidelines.Methods: New, accurate, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of Arterolane maleate and Piperaquine phosphate in pharmaceutical dosage form. The separation was achieved by BDS Hypersil C18, with mobile phase Phosphate Buffer (pH 6): Methanol (80:20 v/v) at a flow rate of 1.0 ml/min. Injection volume 20 μl and wavelength of detection used was 270 nm.Results: The retention time for Arterolane maleate and Piperaquine phosphate were 3.687 min and 5.880 min, respectively. The linearity of proposed method was investigated in range of 3.75-11.25 μg/ml and 18.25-56.25 μg/ml for Arterolane maleate and Piperaquine phosphate respectively. Correlation coefficient value was found to be 0.999 for Arterolane maleate and 0.997 for Piperaquine phosphate. Precision studies showed %RSD values less than 2% for both drugs in all the selected concentrations. The percentage recoveries of Arterolane maleate and Piperaquine phosphate were in the range of 99.63-100.04% and 99.79-100.24% respectively. The limit of detection and limit of quantification were 0.26μg/ml and 0.79 μg/ml for Arterolane maleate and 2.79 μg/ml and 8.45μg/ml for piperaquine phosphate. No interference peaks were found.Conclusions: In Robustness method was unaffected under a variety of conditions including changes of pH and ratio of mobile phase and flow rate so, the method was found to be accurate, precise, specific, sensitive and robust according to acceptance criteria of International Council on Harmonization guidelines.