Determination of Related Substances in Norfloxacin Glutamate and Sodium Chloride Injections / 中国药师

ABSTRACT

Objective:To detect the related substances in norfloxacin glutamate and sodium chloride injections on the basis of nor-floxacin related substances analysis method described in Chinese Pharmacopoeia 2010 edition to establish a more scientific and feasible method. Methods:HPLC was performed under the following conditionsa Diamonsil C18(2)(250 mm ×4.6 mm,5μm) column, mo-bile phase A of 0. 025 mol·L-1 phosphoric acid-acetonitrile(87∶13), phase B of acetonitrile, with gradient elution at a flow rate of 1. 0 ml·min-1 , the detection wavelength of 278nm and 262nm, the injection volume of 20 μl, and the column temperature of 25℃. Results:Under the HPLC conditions, the samples had good stability and separation. An excellent linear relationship was achieved within the range of 0. 032-3. 179μg·ml-1(r=1. 000 0),the detection limit of impurity A was 0. 159 ng,and the average recovery was 98. 3% with RSD of 0. 64%(n=9). Conclusion:Compared with the existing methods, the gradient elution method is accurate, sen-sitive, specific and reproducible, and can be used in the determination of related substances in norfloxacin glutamate and sodium chlo-ride injections.