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目的:建立高效液相色谱法测定普依司他盐酸盐原料药含量。方法:采用Waters Xbridge C18色谱柱(150 mm×4.6 mm,5μm),以0.01 mol·L~(-1)磷酸二氢钠缓冲液(p H=3.0)-乙腈为流动相,梯度洗脱,流速1.0 m L·min~(-1),柱温30℃,检测波长280 nm。结果:普依司他盐酸盐在6.25~200μg·m L~(-1)范围内,峰面积与浓度呈良好线性关系(R2=0.999 7,n=6)。平均回收率为100.40%(RSD=1.13%,n=9)。结论:该方法简便快速、准确灵敏、重复性好,可用于普依司他盐酸盐原料药含量测定。
Objective: To establish a HPLC method for the determination of prudinostat hydrochloride. METHODS: Waters Xbridge C18 column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase with gradient elution of 0.01 mol·L -1 sodium dihydrogen phosphate buffer (p H = 3.0) The flow rate was 1.0 m L · min -1, the column temperature was 30 ℃ and the detection wavelength was 280 nm. Results: There was a good linear relationship between peak area and concentration of pristinol hydrochloride (R2 = 0.999 7, n = 6) in the range of 6.25-200 μg · m L -1. The average recovery was 100.40% (RSD = 1.13%, n = 9). Conclusion: The method is simple and rapid, accurate and sensitive, reproducible, and can be used for the determination of PuI sestat hydrochloride.