Objective: To establish an HPLC method for simultaneous determination of 9 related substances including impurity A-I in loratadine. Methods: The determination was performed on a YMC-Triart C18 column(250 mm×4.6 mm,5 μm). The mobile phase consisted of sodium heptanesulfonate buffer solution and acetonitrile with gradient elution. The flow rate was 1.0 mL·min-1, the column temperature was maintained at 40 ℃, the detection wavelength was set at 254 nm, and the injection volume was 20 μL. Results: The resolutions between the peaks of reference substance loratadine and nine known impurities (including impurities A-I) were good. The calibration curves of reference substance loratadine and impurities A-I were linear in their respective weight ranges of 0.215-10.712 μg·mL-1(r=0.999 9), 0.544-10.930 μg·mL-1(r=0.999 9), 0.202-10.108 μg·mL-1(r=1.000), 0.202-10.141 μg·mL-1(r=1.000), 0.198-9.923 μg·mL-1(r=1.000), 0.580-11.625 μg·mL-1(r=1.000 0), 0.489-9.783 μg·mL-1(r=0.999 9), 0.223-11.249 μg·mL-1(r=1.000), 0.197-9.874 μg·mL-1(r=0.999 9)and 0.199-9.971 μg·mL-1(r=1.000). The limits of quantitation were 0.078, 0.302, 0.146, 0.102, 0.075, 0.251, 0.242, 0.088, 0.196 and 0.127 μg·mL-1. The recoveries (n=9) of impurities A-I were 98.1%, 100.0%, 97.4%, 100.2%, 98.3%, 102.1%, 102.0%, 100.0% and 97.3%, respectively. The determination results of the four manufactures samples showed that the content of impurity F of one manufacture was high, which worthed attention. Conclusion: This method is sensitive and specific, which can distinguish the quality of loratadine from different manufacturers, and can be used for the determination of related substances in loratadine API.
LIU Jing-jing, WEI Xiao-yi, JING Kun, LIU Min, LI Yu-lan, WANG Tie-jie
. Determination of related substances in loratadine by HPLC*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(6)
: 1036
-1043
.
DOI: 10.16155/j.0254-1793.2023.06.15
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