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Development and Validation of a Liquid Chromatography Method for the Analysis of Paromomycin Sulfate and its Impurities

Ying Liu, Shaorui Hou, Liping Wang and Shuxian Yang

A rapid and simple method for the separation and quanti fi cation of paromomycin sulfate and its impurities by HPLC coupled with evaporative light scattering detection (ELSD) was developed. The chromatographic conditions included the use of a GRACE Alltima C 18 column (250mm×4.6mm, 5 μ m) maintained at 30°C and a mobile phase of 0.2 M tri fl uoroacetic acid water–acetonitrile (96:4, v/v) at a fl ow rate of 0.6 mL/min. The in fl uence of gas pressure and temperature of the drift tube in the detector on the detection response was also investigated. A system suitability test to check the quality of the separation was speci fi ed. The method showed good repeatability, linearity and robustness. It also enabled the simultaneous determination of the inorganic counter ions (sulfates).