HPLC法测定尼美舒利胶囊有关物质

Detection of the impurities in nimesulide capsules by RP-HPLC

目的HPLC法测定尼美舒利胶囊中的有关物质。方法D iamonsil-C18柱,甲醇-0.1%(ρ)磷酸氢二钠溶液(体积比65∶35)为流动相,流速为1.0 mL/m in,检测波长254 nm,柱温为室温。结果该法能有效地分离胶囊中的尼美舒利及有关物质,各杂质峰面积的和不大于1%对照溶液的尼美舒利主峰面积。结论该方法可测定尼美舒利胶囊的有关物质,方法准确、可靠。

Objective To detect the impurities in nimesulide capsules by RP-HPLC. Method The analysis was performed on a Diamonsil- C18 column . The mobile phase was methonel-0. 1% Na2HPO4 solution（65：35 ）. The flow rate was 1.0 mL· min^-1 and the detection wavelength 254 nm. Results The HPLC method can separate nimesulide and the impurities in nimesulide capsules. Conclusion The method is stable and reliable, which can be used for the quality control of nimesulide capsules.