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目的:建立盐酸肼屈嗪片的HPLC含量测定方法。方法:色谱柱为NUCLEODUR C_(18)(150 mm×4.6 mm,5μm),流动相为0.28%磷酸二氢钾溶液(用磷酸调pH至3.0)-甲醇(95:5),流速为1.0 ml·min~(-1),检测波长为260 nm,柱温为40℃。结果:盐酸肼屈嗪在20.3～203μg·ml~(-1)浓度范围内,与峰面积呈良好的线性关系(r=0.999 6),平均回收率为100.1%,RSD= 1.1%(n=9)。结论:方法专属性强、灵敏度高、适用于肼屈嗪片的质量控制。
Objective: To establish a HPLC method for the determination of hydralazine hydrochloride tablets. METHODS: The chromatographic column was NUCLEODUR C18 (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.28% potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid) -methanol (95: 5) at a flow rate of 1.0 ml · Min -1, the detection wavelength was 260 nm and the column temperature was 40 ℃. Results: Hydralazine hydrochloride had a good linear relationship with the peak area (r = 0.999 6) in the range of 20.3 ~ 203μg · ml ~ (-1), with an average recovery of 100.1% and a RSD of 1.1% (n = 9). Conclusion: The method is highly specific and sensitive and suitable for the quality control of hydralazine tablets.