目的 建立替米沙坦中有關(guān)物質(zhì)的測定方法。方法 采用反相高效液相色譜（RP-HPLC）法，使用Dikma Diamonsil C18色譜柱（150 mm×4.6 mm，5 μm），[磷酸二氫鉀–戊烷磺酸鈉緩沖液（pH 3.0）]–[甲醇–乙腈（20∶80）]線性梯度洗脫，檢測波長為230 nm，體積流量為1.0 mL/min，柱溫為35 ℃。結(jié)果 在上述色譜條件下，5種雜質(zhì)能與替米沙坦有效地分離，分離度大于1.5，檢出限為0.1 ng。結(jié)論 使用本方法測定替米沙坦中有關(guān)物質(zhì)，能有效檢出特定雜質(zhì)，方法準(zhǔn)確、快速、重復(fù)性好。

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.