Quantitative analysis of genotoxic impurity 7,8-didehydronaloxone in Oxycodone and Naloxone Hydrochloride Sustained-release Tablets by UHPLC-MS/MS
ZHANG Li
QU Hongliang
SUN Qiquan
YUAN Feifei
XUE Yunli
Abstract：Objective To establish an UHPLC-MS/MS method for determination of potential genotoxic impurity 7,8-didehydronaloxone in Oxycodone and Naloxone Sustained-release Tablets.Methods The separation was performed on Wa-ters Acquity CSH C18(2.1 mm×150 mm,1.7 μm)column with the mobile phase consisting of 0.77 g·L-1 ammonium acetate aqueous solution(mobile phase A)and acetonitrile(mobile phase B)under a gradient elution at a flow rate of 0.5 mL·min-1 and a column temperature of 50 ℃.Multiple reaction monitoring(MRM)mode was used to quantitative detection of 7,8-di-dehydronaloxone in Oxycodone and Naloxone Sustained-release Tablets.Results The calibration curves was in good linear-ity for 7,8-didehydronaloxone in the range of 1.2～48 ng·mL-1.The LOD and LOQ were 0.6 ng·mL-1 and 1.2 ng·mL-1,re-spectively.The recoveries at low,middle,and high spiked concentrations was 93％～99％(n=9),and the RSD was 2.4％.Conclusion The method was sensitive and accurate,which can be applied for the quantifications of 7,8-didehydronaloxone in Oxycodone and Naloxone Sustained-release Tablets,providing scientific basis and quantitative analysis method for impurity control of Oxycodone and Naloxone Sustained-release Tablets.
Keywords：Oxycodone and Naloxone Sustained-release TabletsPotential genotoxic impurity78-didehydronaloxoneUHPLC-MS/MSQuantitative analysis
Publication Date：2025-01-27
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 32-35 )