Yang Yong-jian
2010
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Journal
Chinese Journal of New Drugs
Abstract
Objective:To establish a RP-HPLC method for simultaneous determination of related substances and content of naphthoquine phosphate for quality control.Methods: An Agilent SB-C8 column(150mm×4.6mm,5μm) was used with 0.1% trifluoroacetic acid(pH adjusted to 3.0 with triethylamine) as mobile phase A and acetonitrile as mobile phase B.Gradient elution was used for the determination of related substances and the flow rate was 1.0mL·min-1.Isocratic elution was used for the determination of content and the flow rate was 0.5mL·min-1.The detection wavelength was 275nm,and the column temperature was maintained at 35℃.Results: The calibration curves of chemically synthetic intermediates I~IV were linear in the concentration ranges of 2.057~51.428,2.333~58.336,1.766~44.140 and 2.113~52.828μg·mL-1,respectively.The average recoveries were 96.1%~99.6% with RSDs of 0.8%~3.0%,and LODs were 0.5~8.8ng.The linear range for naphthoquine phosphate was 114.16~266.38μg·mL-1(r=0.9999),and RSD of low,mediate and high concentrations was 0.24%(n=9).Conclusion: The method is sensitive,reliable and specific,and can be used for the quality control of naphthoquine phosphate.