Determination of Content and Related Substances of Flibanserin by HPLC-DAD / 中国药师

ABSTRACT

Objective:To establish an HPLC method for the determination of flibanserin and its related substances. Methods: A Phenomenex Luna C18 column(150 mm × 4. 60 mm, 5 μm) was used, the mobile phase consisted of 0. 02 mol·L-1 potassium di-hydrogen phosphate solution (pH was adjusted to 6. 0 by sodium hydroxide)-methanol and acetonitrile (41), the flow rate was 1. 0 ml·min-1 , the column temperature was 30℃, the detection wavelength was 260 nm, and the injection volume was 10 μl. Results:Flibanserin and all the related compounds could be well separated. The linear range was 20-500 μg·ml-1(r=0. 9998), the average recovery was 100. 0%(RSD=0. 90%,n=9). The content of the main component in 4 batches of samples was 99. 6%, 99. 8%, 100. 4% and 99. 4%, respectively. The single impurity limit was set at 0. 1% and the limit of total impurities was set at 0. 5%. Con-clusionThe method is specific and accurate, which can be applied in the determination of content and related substances of fliban-serin.