Research and Determination of Related Substances in Ritonavir Starting Material
OBJECTIVE To establish an efficient liquid chromatography method for the determination of related substances in N-[N-methyl-N-[(2-isopropyl-4-thiazolyl)methyl amino]carbonyl]-L-valine.METHODS A gradi-ent elution was performed on an Agilent Poroshell 120 Phenyl-Hexyl(100 mm ×4.6 mm,2.7 μm)column with wa-ter-acetylene-trifluorocetic acid(90∶10∶0.1)as mobile phase A,and acetylene-methanol-trifluorocetic acid(50∶50∶0.1)as mobile phase B at a flow rate of 1.0 mL·min-1.The detection wavelength was 220 nm,the column temperature was 35 ℃.RESULTS Ritonavir starting material and its impurities showed good linear relationship(r ≥ 0.990);The average recoveries of impurities were within 86.7％-115.1％,and the RSD(n=9)of the recovery rate was less than 8.5;The separation degree between the peaks of related substances and the principal peak obtained in chromat-ogram of the system suitability solution were greater than 1.5.CONCLUSION The detection method has high sen-sitivity,strong specificity,and high accuracy.It could be used for the determination of related substances of ritonavir starting material.
High performance liquid chromatographyRitonavir starting materialRelated SubstancesQuality control
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维普
