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[摘要]
目的 建立替米沙坦中有关物质的测定方法。方法 采用反相高效液相色谱(RP-HPLC)法,使用Dikma Diamonsil C18色谱柱(150 mm×4.6 mm,5 μm),[磷酸二氢钾–戊烷磺酸钠缓冲液(pH 3.0)]–[甲醇–乙腈(20∶80)]线性梯度洗脱,检测波长为230 nm,体积流量为1.0 mL/min,柱温为35 ℃。结果 在上述色谱条件下,5种杂质能与替米沙坦有效地分离,分离度大于1.5,检出限为0.1 ng。结论 使用本方法测定替米沙坦中有关物质,能有效检出特定杂质,方法准确、快速、重复性好。
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[Abstract]
Objective To establish a method for the determination of related substances in telmisartan. Methods The RP-HPLC method was carried out using a Dikma Diamonsil C18 column (150 mm×4.6 mm, 5 μm), the mobile phase consisted of KH2PO4-pentane sulfonic acid sodium salt buffer (pH 3.0) and methanol-acetonitrile (20∶80) with linear gradient elution, the detective wavelength was at 230 nm with the flow rate of 1.0 mL/min and the temperature at 35 ℃. Results Five impurities were effectively separated from telmisartan with separating degree (R)>1.5, and detection limit 0.1 ng. Conclusion The related substances could be determined from telmisartan by the method, and this method with better reproducibility is precise and rapid.
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