Determination of the impurity C in phenylephrine hydrochloride by main constituent own control method with correction factor
XU Liang-liang
ZHU Xiao-lin
SU Li
Abstract：Objective To establish a method for the determination of impurity C in phenylephrine hydrochloride by main constituent own control method with correction factor. Methods The assay was carried out on a C18 column(4. 6 mm × 250 mm,5 μm)with the mobile phase of acetonitrile - 0. 325% sodium sulfonate solution(with phosphoric acid to adjust pH value of 2. 8)(10:90)at a flow rate of 1. 5 mL·min - 1. The column temperature,the detection wave length and the in-jection volume were set at 45 ℃,215 nm,and 20 μL. The relative retention time and the correction factor between impurity C and phenylephrine hydrochloride were determined. Results The linear ranges of impurity C and phenylephrine hydro-chloride were 0. 065 1 ~ 1. 626 9 μg·mL - 1 ,0. 064 7 ~ 1. 618 4 μg·mL - 1 ,respectively. The relative retention time be-tween impurity C and phenylephrine hydrochloride was 1. 3,the correction factor between impurity C and phenylephrine hydrochloride was 0. 50. Conclusion This method was simple,accurate and reliable to determine impurity C in phenyleph-rine hydrochloride. without standard substances.
Keywords：Phenylephrine hydrochlorideImpurity CCorrection factor
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 706-708,718 )