Determination of Isomeric Impurity in Fasudil Hydrochloride by HPLC / 中国药师

ABSTRACT

Objective:To establish an HPLC method for the determination of isomeric impurity in fasudil hydrochloride. Meth-odsThe chromatographic method was carried out on a Kromasil 100-5 Phenyl C18 column with phenyl bonded silica as the filler (250 mm × 4. 6 mm, 5 μm), and phosphate buffer (10 mmol· L-1 ammonium dihydrogen phosphate, adjusting pH to 4. 0 with 1% phos-phoric acid) -acetonitrile (80∶ 20) was used as the mobile phase. The detection wavelength was 275nm and the column temperature was 40℃. The flow rate was 1. 0 ml· min-1 , and the injection volume was 10 μl. Results:Fasudil hydrochloride and its derivative was linear within the range of 0. 148-2. 960 μg·ml-1(r=1. 0000) and 0. 101-2. 014μg·ml-1(r=0. 999 9), respectively. The av-erage recovery of isomer impurity in fasudil hydrochloride was 101. 9% with RSD of 0. 98%(n=9). Conclusion:The method is sim-ple,accurate and reproducible,which can be used for the quality control of fasudil hydrochloride and its isomer.