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目的:建立HPLC法测定盐酸阿扎司琼原料药中的主药含量。方法:采用外标法,使用Phenomenex Luna5u C18(2)100A色谱柱(250 mm×4.6 mm,5μm),磷酸盐缓冲液-乙腈(82∶18)为流动相,流速为1.0 mL.min-1,检测波长为305 nm,柱温为35℃。结果:盐酸阿扎司琼进样质量在2.01～20.08μg范围内,与色谱峰面积的线性关系良好(r=0.999 9)。测得3批原料药中盐酸阿扎司琼质量分数分别为99.6%、99.9%和99.5%,与非水滴定法的测定结果相近。结论:该法准确、便捷、低污染,可用于盐酸阿扎司琼原料药中主药含量的测定。
OBJECTIVE: To establish a HPLC method for the determination of the main drug in the pharmaceuticals of azacitidine hydrochloride. METHODS: Phenomenex Luna 5u C18 (2) 100A column (250 mm × 4.6 mm, 5 μm) and phosphate buffer-acetonitrile (82:18) were used as the mobile phase at a flow rate of 1.0 mL · min- , The detection wavelength was 305 nm, the column temperature was 35 ℃. Results: The injection quality of 2.0% ~ 20.08μg of azasetron hydrochloride showed a good linear relationship with the chromatographic peak area (r = 0.999 9). Measured three batches of drug substance in the mass fraction of atazan hydrochloride hydrochloride were 99.6%, 99.9% and 99.5%, respectively, and non-aqueous titration determination results are similar. Conclusion: The method is accurate, convenient and low pollution and can be used for the determination of the main drug content in the pharmaceutical raw materials of azasetron hydrochloride.