目的 建立测定塞来昔布原料药中有关物质的高效液相色谱（HPLC）法。方法 建立HPLC法，采用Century SILC30色谱柱（250 mm×4.6 mm，5 μm），流动相：水（A）-乙腈（B）-甲醇（C），梯度洗脱；体积流量：1.0 mL/min；检测波长：215 nm；柱温：25℃；进样量：20 μL。结果 塞来昔布与各杂质的分离度良好，且在一定浓度范围内线性关系良好。塞来昔布和杂质A、B、C、D、F的定量限分别为198.0、161.2、240.0、239.4、203.5、156.8 ng/mL，检测限分别为40.3、50.0、39.9、61.0、39.2、24.8 ng/mL。结论 本法操作简单，准确度、灵敏度高，可用于塞来昔布原料药中有关物质的分离检测。

Objective To establish an HPLC method for determination of the related substances in celecoxib active pharmaceutical ingredients.Methods HPLC method was established. The determination was carried out on Century SIL C30 column (250 mm×4.6 mm, 5 μm). The mobile phase consisted of water - acetonitrile - methanol with gradient elution. The flow rate was 1.0 mL/min. The detective wavelength was set at 215 nm, column temperature was 25 ℃, and the injection volume was 20 μL.Results Celecoxib and its related impurities had good separation, and there were good linear relationship within a certain concentration ranges. The quantitative limits of cecoxib and impurity A, B, C, D, and F were 198.0, 161.2, 240.0, 239.4, 203.5, and 156.8 ng/mL, respectively. The detection limits were 40.3, 50.0, 39.9, 61.0, 39.2, and 24.8 ng/mL.Conclusion The method is simple, accurate, sensitive, and suitable for the determination of related substances in celecoxib active pharmaceutical ingredients.