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目的:建立反相高效液相色谱(RP-HPLC)法测定原料药3-氯-3’,4’-二羟基二苯甲酮(HP46)的含量及有关物质。方法:采用Diamonsil C18(250mm×4.6mm,5μm)色谱柱,以甲醇-乙腈-水(用磷酸调节pH至3.0)(65∶5∶30)为流动相,流速0.8mL.min-1,检测波长243nm,柱温25℃,外标法测定HP46含量,自身对照法测定有关物质。结果:有关物质与主药分离良好,主药含量高于99%,HP46在3.0~180mg.L-1范围内线性关系良好(r=0.999 9),最低检测限1mg.L-1。结论:建立的高效液相色谱方法灵敏性和专属性好,适用于原料药HP46的质量控制、有关物质检测和稳定性检查。
Objective: To establish a reversed-phase high performance liquid chromatography (RP-HPLC) method for the determination of 3-chloro-3 ’, 4’-dihydroxybenzophenone (HP46) METHODS: Diamonsil C18 (250 mm × 4.6 mm, 5 μm) column was used with methanol-acetonitrile-water (adjusted to pH 3.0 with phosphoric acid) (65: 5: 30) Wavelength of 243nm, column temperature 25 ℃, external standard method for the determination of HP46 content, its own control method for the determination of related substances. Results: The relevant substances were well separated from the main drug, with the main drug content higher than 99%. HP46 had a good linear relationship (r = 0.999 9) in the range of 3.0-180 mg.L-1 and the lowest detection limit was 1 mg.L-1. Conclusion: The established HPLC method has good sensitivity and specificity, and is suitable for the quality control of drug substance HP46, related substance detection and stability check.