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| HPLC法测定注射用单磷酸阿糖腺苷中的有关物质 |
| Determination of Related Substances in Vidarabine Monophosphate for Injection by HPLC |
| 投稿时间：2014-10-24 修订日期：2015-01-05 |
| DOI： |
| 中文关键词: 注射用单磷酸阿糖腺苷 有关物质 阿糖腺苷 腺嘌呤 高效液相色谱 杂质检测 |
| 英文关键词:Vidarabine monophosphate for injection Related substances Vidarabine Adenine HPLC Impurity assay |
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| 中文摘要: |
| 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，5 μm）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：20 μl；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 0 μg·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。 |
| 英文摘要: |
| ABSTRACT 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 C18 column（250 mm×4.6 mm，5 μm） with the mobile phase consisting of water（containing 10 mmol·L-1 tetrabutyl ammonium hydroxide and 10 mmol·L-1 potassium dihydrogen phosphate） methanol（80∶20）at a flow rate of 1.0 ml·min-1, the detection wavelength was set at 258nm，the column temperature was at 30℃, and the sample size was 20μl. 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 7μg·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. |
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