目的 采用高效液相色譜法建立鹽酸法舒地爾中雜質(zhì)檢查和二聚體的測(cè)定。方法 用Venusil XBP C18柱（250 mm×4.6 mm，5 μm），甲醇–水（50∶50，含10 mmol/L庚烷磺酸鈉和5 mmol/L磷酸二氫鈉，用磷酸調(diào)pH 3.0）為流動(dòng)相；紫外檢測(cè)波長(zhǎng)為275 nm；進(jìn)樣量10 μL；體積流量1.0 mL/min。采用自身對(duì)照法測(cè)定雜質(zhì)，標(biāo)準(zhǔn)曲線法測(cè)定二聚體。結(jié)果 鹽酸法舒地爾中4個(gè)單一雜質(zhì)量的均值不大于1.34%，之和的均值不大于1.38%。鹽酸法舒地爾二聚體在0.63～41.60 μg/mL線性關(guān)系良好，r＝0.999 9；平均回收率為99.5%，RSD值為1.3%。結(jié)論 本方法簡(jiǎn)便、準(zhǔn)確、專屬性強(qiáng)，可作為鹽酸法舒地爾中雜質(zhì)檢查及二聚體的測(cè)定方法。

Objective To develop an RP-HPLC method for determination of the impurities and dimers in fasudil hydrochloride. Methods Venusil XBP C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was composed of methanol-H2O (50∶50, including 10 mmol/L sodium heptane-1-sulphonate and 5 mmol/L sodium dihydrogen phosphate, pH 3.0). The flow rate was 1.0 mL/min, and the determination wavelength was set at 275 nm with the injection volume of 10 μL. The total impurities were determined by the principal self contrast method, at the same time the dimmer contents in the sample were determined by standard curve method. Results Each and total contents of four impurities in fasudil hydrochloride were below 1.34% and 1.38%. A linearity between peak areas and dimer content was achieved in the range of 0.63—41.60 μg/mL(r = 0. 999 9), and the average recovery was 99.5%, with an RSD value of 1.3%. Conclusion The method is simple, accurate, and sensitive, and could be used for the assay and quality control of impurities and dimers in fasudil hydrochloride.