Determination of Mannityl Nicotinate and Related Substances by HPLC / 中国药师

ABSTRACT

Objective: To establish an HPLC method for the determination of mannityl nicotinate and its related substances. Methods:The HPLC method was performed on an Agilent Extend-C18 column (250 mm × 4. 6 mm, 5 μm) with the mobile phase of 0. 01 mol·L-1 ammonium acetate solution-methanol(40∶60). The detection wavelength was 264nm. The column temperature was 30℃. The flow rate was 1. 0 ml·min-1 and the injection volume was 10 μl. Results: The linear range of mannityl nicotinate was 53. 6-1 072. 8 μg·ml-1(r=1. 000 0), and the mean recovery was 98. 9%(RSD=0. 4%,n=9). Mannityl nixotinate and its related substances could be well separated. The limit of quantitation was 0. 06 μg·ml-1 and the limit of detection was 0. 02 μg·ml-1 . Con-clusionThe method is specific, accurate and rapid. It is suitable for the quality control of mannityl nicotinate.