Development and validation of stability indicating RP-HPLC method for simultaneous estimation of Arterolane Maleate and Piperaquine Phosphate in pharmaceutical dosage form

A simple, sensitive, robust and reproducible method for the simultaneous estimation of Arterolane maleate and Piperaquine phosphate in formulation was developed using Reverse phase high performance liquid chromatographic method. Reversed-phase chromatography was performed on Shimadzu Model SPD-20AT, using a mixture of phosphate buffer (pH-6.0): Methanol (80:20v/v) as a mobile phase with a flow rate of 1.0 ml/min. The analyte was examined with UV detector at 270 nm. In the developed method Arterolane maleate elutes at 3.687 min and Piperaquine phosphate at 5.880 min. The linearity of developed method was achieved in the range of 3.75-11.25 µg/ml for Arterolane maleate and 18.25-56.25 µg/ml for Piperaquine phosphate. The method was validated with respect to Linearity, Accuracy, Limit of Detection, Limit of Quantification, Robustness, System Suitability and Stability as per ICH guidelines. Arterolane maleate and Piperaquine phosphate were subjected to stress conditions including acidic, alkaline, oxidation, thermal and sunlight degradation. In these studies, 10.45% Arterolane maleate and 13.27% of Piperaquine phosphate were degraded in 0.1N HCl (1 hour). In 0.1 N NaOH (1 hour) 3.3% Arterolane maleate degradation and 25.38% Piperaquine phosphate degradation was observed. While treatment with 3% H2O2(1 hour) showed degradation of Arterolane maleate 15.41% and of Piperaquine phosphate 20.65%.Thermal exposure (half hour) showed 4.53% degradation of Arterolane maleate and 16.37% of Piperaquine phosphate. Sun light exposure (2 hour) showed 21.25% and 26.87% degradation of Arterolane maleate and Piperaquine phosphate respectively. Data revealed that developed method can be applied for routine quality control analysis for these drugs in pharmaceutical dosage form.

Author(s): Ankita S. Bhavsar, Seju D. Patel and Janki R. Patel

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