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目的建立反相高效液相色谱法(RP-HPLC)测定达格列净的有关物质。方法采用Kromasi L 100-5-C18色谱柱(4.6 mm×250 mm,5μm);以水为流动相A,乙腈为流动相B进行线性梯度洗脱;流速为1.0 ml/min;检测波长为224 nm;柱温为30℃。结果达格列净与相关杂质均分离度良好;达格列净与特定杂质Dapa-7e、Dapa-22的线性范围分别为0.1747~4.3686μg/ml、0.2320~5.7997μg/ml和0.1970~4.9260μg/ml,r均>0.999,方法准确度均>99.0%。结论本方法简便、准确、迅速,可用于达格列净中有关物质的测定。
Objective To establish a reversed-phase high performance liquid chromatography (RP-HPLC) for the determination of dapagliflozin-related substances. Methods A Kromasi L 100-5-C18 column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase A consisted of acetonitrile and mobile phase B with a linear gradient of 1.0 ml / min. The detection wavelength was 224 nm; column temperature is 30 ℃. Results Dapagliflozin and related impurities were well separated. The linear ranges of dapagliflozin and Dapa-7e and Dapa-22 were 0.1747 ~ 4.3686μg / ml, 0.2320 ~ 5.7997μg / ml and 0.1970 ~ 4.9260μg / ml, r> 0.999, the accuracy of the method were> 99.0%. Conclusion The method is simple, accurate and rapid and can be used for the determination of related substances in dapagliflozin.