Determination of Related Substances in Lorcaserin Hydrochloride by HPLC / 中国药房
China Pharmacy
; (12): 5150-5153, 2017.
Article
de Zh
| WPRIM
| ID: wpr-704497
Bibliothèque responsable:
WPRO
ABSTRACT
OBJECTIVE:To establish a method for the determination of related substances in lorcaserin hydrochloride.METHODS:HPLC method was adopted.The determination was performed on Welch ultimate XB-ODS column with mobile phase consisted of Sodium dihydrogen phosphate (pH =6.5)-acetonitrile (gradient elution) at the flow rate of 1.0 mL/min.The detection wavelength was set at 220 nm,and column temperature was 35 ℃.The sample size was 20 μL.RESULTS:The linear ranges of impurity 1,2,3 were 0.075 60-7.560 μg/mL(r=0.999 9),0.081 40-8.140 μg/mL(r=0.999 9),0.099 24-9.924 μg/mL(r=0.999 9),respectively.The limits of quantification were 0.075 60,0.081 40,0.099 25 μg/mL.The limits of detection were 0.022 68,0.024 42,0.029 77 μg/mL.RSD of precision test was lower than 2.0%.Impurity 1 was found in stability test and reproducibility test,RSD<2.0%.The recoveries were 98.53%-102.45% (RSD=1.06%,n=9),98.26%-101.64% (RSD=1.03 %,n=9),100.08%-102.10% (RSD=0.70%,n=9),respectively.CONCLUSIONS:The method is sensitive,rapid,accurate and reliable,which can be used to determine the related substances of lorcaserin hydrochloride.
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WPRIM
langue:
Zh
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China Pharmacy
Année:
2017
Type:
Article