建立了高效液相色谱法（HPLC）测定艾拉莫德起始原料2-甲氧基-4-甲磺酰胺基-5-苯氧基苯乙酮中基因毒性杂质4-氯-3-硝基苯甲醚、3-硝基-4-苯氧基苯甲醚含量的方法。用35%（体积分数）乙腈溶液于50 ℃水浴中超声溶解供试品，加入0.2%（体积分数）磷酸溶液，在冰水浴中析晶约30 min。取上清液过0.45 μm滤膜，滤液供HPLC分析。以Wondasil C₁₈色谱柱为固定相，以不同体积比的乙腈和0.01 mol·L^-1磷酸盐缓冲液（pH 9.0）的混合液为流动相进行梯度洗脱，用光电二极管阵列检测器在检测波长222 nm处检测2种目标物。结果显示：2种目标物的质量浓度均在0.03~0.60 mg·L^-1内与其对应的峰面积呈线性关系，检出限（3S/N）为9.97，10.04 μg·L^-1；对实际样品进行加标回收试验，所得回收率分别为94.5%~104%，89.0%~104%。对实际样品进行重复性（n=6）和中间精密度（n=12）试验，所得2种目标物测定值的相对标准偏差分别为3.2%，4.5%（重复性试验）和4.4%，6.2%（中间精密度试验）。

A method for the determination of genotoxic impurities of 4-chloro-3-nitroanisole and 3-nitro-4-phenoxyanisole in N-(4-acetyl-5-methoxy-2-phenoxyphenyl)methanesulfonamide, the starting material of iguratimod, was established by HPLC. 35% (φ) acetonitrile solution was used to ultrasonically dissolve the test sample in a 50 ℃ water bath, 0.2% (φ) phosphoric acid solution was added, and the mixed solution was placed in an ice water bath to crystallize for ca. 30 min. The supernatant was taken and passed through a 0.45 μm filter membrane, and the filtrate was used for HPLC analysis. Wondasil C₁₈ column was used as the stationary phase, and a mixture of acetonitrile and 0.01 mol·L^-1 phosphate buffer solution (pH 9.0) at various volume ratios was used as mobile phase for gradient elution. Two targets obtained were detected at the wavelength of 222 nm with photodiode array detector. The results showed that the mass concentrations of the 2 targets in the range of 0.03-0.60 mg·L^-1 were linearly related with the corresponding peak areas, with detection limits (3S/N) of 9.97, 10.04 μg·L^-1, respectively. Test for recovery was made on the actual samples by standard addition method, giving values of recovery in the range of 94.5%-104% and 89.0%-104%, respectively. RSDs of the determined values of 2 targets of tests for repeatability (n=6) and intermediate precision (n=12) on the actual samples found were 3.2%, 4.5% (for repeatability test ) and 4.4%, 6.2% (for intermediate precision test), respectively.