目的 分析對比多國藥典改進(jìn)HPLC法測定坎地沙坦酯及其片劑中有關(guān)物質(zhì)的方法。方法 采用HPLC法對坎地沙坦酯及其片劑中9個雜質(zhì)進(jìn)行測定。Waters Symmetry C₁₈色譜柱（150 mm×4.6 mm，5 μm）；流動相：[乙腈-水-冰醋酸（57：43：1）]-[乙腈-水-冰醋酸（90：10：1）]，梯度洗脫；體積流量：0.9 mL/min；柱溫：35℃；樣品倉溫度：10℃；進(jìn)樣量：20 μL；檢測波長：254 nm。結(jié)果 在選定的色譜條件下，坎地沙坦酯與有關(guān)物質(zhì)分離良好。試驗(yàn)專屬性、線性、耐用性良好。結(jié)論 本研究可為坎地沙坦酯片的質(zhì)量標(biāo)準(zhǔn)的制訂和提高提供參考和依據(jù)。

Objective To optimize the HPLC method to determinate the related substances in candesartan cilexetil and its tablets compared with the national pharmacopoeias. Methods Nine impurities in Candesartan Cilexetil Tablets were separated and identified by HPLC. Chromatographic separation was carried out on an Waters Symmetry C₁₈ column (150 mm×4.6 mm, 5 μm) at a flow rate of 0.9 mL/min.[Acetonitrile-water-acetic acid glacial (57:43:1)]-[acetonitrile-water-acetic acid glacial (90:10:1)] was used as mobile phase. It was monitored at a wavelength of 254 nm, the temperatures of column and sample chamber were 35 and 10℃, and the injection volume was 20 μL.. Results There was good separation among candesartan cilexetil and related substances under the chromatographic conditions. The method had good specificity, linearity, and durability. Conclusion It provides reference and basis to develop and improve the quality control of Candesartan Cilexetil Tablets.