[關(guān)鍵詞]
[摘要]
目的 建立替米沙坦中有關(guān)物質(zhì)的測(cè)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(cè)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(cè)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。
[Key word]
[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.
[中圖分類號(hào)]
[基金項(xiàng)目]