HPLC法测定注射用阿扎胞苷的含量

摘要

OBjective ToestablishanHPLDmethodforthedeterminationofAzacitidine.MethodsWelchUltimate XB-D18 column(4. 6 mm × 250 mm,3μm)was used. The mobile phase consisted of 0. 02 mol·L-1 dipotassium hydrogen phosphate solution(adjust pH to 6. 5 by phosphoric acid)-methanol(90:10). The detection wavelength was 243 nm and the column temperature was(15 ± 2)℃. Results The calibration curve was linear in the range of 8. 16~30. 6 μg·mL-1 ( r=0. 999 9 ). The average recoveries was 98. 97% with corresponding RSD of 0. 73%. Conclusion The method had strong specialization and high accuracy,and can be used for the quality control of azacitidine.%目的：建立测定阿扎胞苷含量的高效液相色谱方法。方法采用Welch Ultimate XB-D18（4.6 mm ×250 mm，3μm）色谱柱，以0.02 mol·L-1磷酸氢二钾溶液（以磷酸溶液调pH至6.5）-甲醇（90：10）为流动相，检测波长为243 nm，柱温为（15±2）℃。结果阿扎胞苷浓度在8.16～30.6μg·mL-1浓度范围内线性良好（r=0.9999），平均回收率为98.97%，RSD为0.73%。结论本方法专属性强、准确度高，可用于阿扎胞苷的质量控制。