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Stability indicating RP-HPLC method development for simultaneous determination of arterolane maleate and piperaquine phosphate in bulk and tablet dosage form | Abstract
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Abstract

Stability indicating RP-HPLC method development for simultaneous determination of arterolane maleate and piperaquine phosphate in bulk and tablet dosage form

Author(s): Divya M, Vasanth P M *, Ramesh T and Ramesh M

A simple, accurate, precise and stability indicating HPLC method has been developed and validated for simultaneous determination of Arterolane Maleate and Piperaquine Phosphate in pure and tablet dosage forms. Reversed-phase chromatography was performed on C18 column (Thermo Hypersil 100nm ×4.6× nm× 5μm) with methanol – potassium di hydrogen orthophosphate buffer (50:50v/v),as mobile phase flows at flow rate of 1.0ml/min. Detection was performed at 290 nm. The method was validated with respect to linearity, accuracy, precision and robustness. The degradation behavior of drug was investigated under various stress conditions recommended by International Conference of Harmonisation (ICH) guidelines. The retention times of Arterolane and Piperaquine were 1.32 & 3.42 respectively. The linearity range of Arterolane and Piperaquine 50-150 μg/ml with correlation coefficient of 1.The means recovery study was carried by standard method and results were in range of 101 to 100% for Arterolane and 99.9 to 100.0 % for Piperaquine. The relative standard deviation for method precision studies of Arterolane and Piperaquine was 0.9 & 0.51 respectively and for intraday precision 0.30 & 0.19. The average % assay was 99% for both Arterolane and Piperaquine. There was no interference of peak obtained for degraded product with sample peaks which ensures the specificity of the method. Statistical analysis proved the method was precise, reproducible, selective, specific and accurate for analysis. The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase imply the method is suitable for routine quantification of Arterolane and Piperaquine with high precision and accuracy.