摘要
目的：建立测定注射用单磷酸阿糖腺苷中有关物质的高效液相色谱法。方法：采用Kromasil 100-5 C18（250 mm×4.6 mm,5μm）色谱柱,以水（含10 mmol·L^-1四丁基氢氧化铵与10 mmol·L^-1磷酸二氢钾）-甲醇（80∶20）为流动相;流速为1.0 ml·min^-1,检测波长：258 nm,柱温：30℃;进样量：20μl;应用外标法对注射用单磷酸阿糖腺苷中已知杂质阿糖腺苷和腺嘌呤进行检查,其他未知杂质用主成分自身对照法进行检查。结果：阿糖腺苷和腺嘌呤分别在0.0765-1.530 7μg·mL^-1（r=0.999 9）,0.078 0-1.560 0μg·mL^-1（r=0.999 9）范围内线性关系良好,平均回收率分别为99.8%（RSD=0.2%,n=9）、97.0%（RSD=1.2%,n=9）。结论：该方法可用于注射用单磷酸阿糖腺苷有关物质的测定。
Objective： To establish an HPLC method for the determination of the related substances in vidarabine monophosphate for injection. Methods： The known impurities vidarabine and adenine in vidarabine monophosphate for injection were analyzed by an external standard method on a Kromasil 100-5 C18column（ 250 mm × 4. 6 mm,5 μm） with the mobile phase consisting of water（ containing 10 mmol·L^-1tetrabutyl ammonium hydroxide and 10 mmol·L^-1potassium dihydrogen phosphate）-methanol（ 80 ∶ 20） at a flow rate of 1. 0 ml· min^-1,the detection wavelength was set at 258 nm,the column temperature was at 30℃,and the sample size was20μl. Meanwhile,the unknown impurities were examined by a self-control method. Results： Good linear relationships of vidarabine and adenine were obtained within the range of 0. 0765 - 1. 530 7 μg · mL^-1（ r = 0. 999 9） and 0. 078 0 - 1. 560 0 μg·mL^-1（ r =0. 999 9）. The corresponding average recovery was 99. 8% with RSD of 0. 2%（ n = 9） for vidarabine and 97. 0% with RSD of 1. 2%（ n = 9） for adenine. Conclusion： The method can be used to determine the related substances in vidarabine monophosphate for injection.
出处
《中国药师》
CAS
2015年第4期652-655,共4页
China Pharmacist
