Determination of the Related Substances in Nimesulide Granules by HPLC / 中国药师

ABSTRACT

Objective:To establish an HPLC method for the determination of the related substances in nimesulide granules. Meth-odsAn Agilent HC-C18(250 mm ×4.6 mm,5 μm)column was used, the mobile phase was composed of acetonitrile-0.01 mol ·L-1 ammonium dihydrogen phosphate (adjusting pH to 7. 0 with ammonia) (4060) and the detection wavelength was 230 nm, the flow rate was 1. 0 ml·min-1 ,the column temperature was 30℃, and the injection volume was 20μl. Results:The linear range of nimesu-lide was 0. 10-0. 30 mg·ml-1(r=0. 999 9). Nimesulide and its related substances could be well separated with the peak separation degree above 2. 0. The limit of detection and the limit of quantification was 0. 3 ng and 1. 0 ng, respectively. Conclusion:The method is simple, accurate and reproducible, which can be used for the quality control of nimesulide granules.