Development and validation of UPLC method for determination of primaquine phosphate and its impurities

With the objective of reducing analysis time and maintaining good efficiency, there has been substantial focus on high-speed chromatographic separations. Recently, commercially available ultra-performance liquid chromatography (UPLC) has proven to be one of the most promising developments in the area of fast chromatographic separations. In this work, a new isocratic reverse phase chromatographic method was developed using UPLC for primaquine phosphate bulk drug. The newly developed method is applicable for assay and related substance determination of the active pharmaceutical ingredient. The chromatographic separation of primaquine and impurities was achieved on a Waters Acquity BEH C18, 50 x 2.1 mm, 1.7 mu m column within a short runtime of 5 min. The method was validated according to the regulatory guidelines with respect to specificity, precision, accuracy, linearity and robustness. Forced degradation studies were also performed for primaquine phosphate bulk drug samples to demonstrate the stability indicating power of the UPLC method. Comparison of system performance with conventional HPLC was made with respect to analysis time, efficiency and sensitivity. (C) 2007 Elsevier B.V. All rights reserved.