目的:建立RP-HPLC法测定氨来呫诺有关物质及糊剂含量.方法选用SHIMADZU VP-ODS柱(250mm×4.6mm,5μm),甲醇-0.01mol·L-1磷酸二氢铵(70∶30,用10%磷酸调pH=4.8)为流动相,检测波长为244nm(有关物质)和350nm(含量测定),流速为1.0mL·min-1。结果:该方法的线性范围为4～20μg·mL-1(r=0.9995);低、中、高3种浓度的平均回收率(n=3)分别为99.4%(RSD=1.1%),98.9%(RSD=0.92%),99.7%(RSD=1.3%);最小检测限为0.5ng(S/N≥3)。结论:该方法分离效果好,灵敏度高,重复性好,结果准确可靠。 OBJECTIVE: To establish a RP-HPLC method for the determination of amiloxanil-related substances and pastes.METHODS SHIMADZU VP-ODS column (250 mm × 4.6 mm, 5 μm), methanol-0.01 mol·L-1 ammonium dihydrogen phosphate 30, adjusted to pH 4.8 with 10% phosphoric acid) as the mobile phase at a detection wavelength of 244 nm (related substance) and 350 nm (assay) at a flow rate of 1.0 mL · min -1. Results: The linear range of this method was 4 ~ 20μg · mL-1 (r = 0.9995). The average recoveries of three concentrations were 99.4% (RSD = 1.1%), 98.9 % (RSD = 0.92%), 99.7% (RSD = 1.3%). The minimum detection limit was 0.5ng (S / N≥3). Conclusion: The method has good separation effect, high sensitivity, good repeatability and accurate and reliable results.