Dou Xiao-wen
2013
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Journal
Drugs and Clinic
Abstract
Objective To develop an RP-HPLC method for determination of the impurities and dimers in fasudil hydrochloride. Methods Venusil XBP C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was composed of methanol-H 2 O (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.