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Determination of the Related Substances in Hydrocodone Bitartrate Raw Material by RP-HPLC

LI Shi-cao,LI Hong-ming,YANG Hong,MA Yu-jie,PU Gang(Sichuan Industrial Institute of Antibiotics,Sinopharm Co.,Ltd.,Chengdu 610051,China)  
OBJECTIVE: To establish a method for the determination of related substances in hydrocodone bitartrat raw material,i.e.morphia,dihydrocodeine,codeine,oxycodone,codeinone,methylcodeine,benzophenone and thebaine.METHODS: RP-HPLC method was adopted with gradient elution.The determination was Inertsil ODS-2 column with mobile phase consisted of sodium octanesulphonate-acetonitrile(gradient elution) at the flow rate of 1.5 mL·min-1.The detection wavelength was set at 283 nm,and column temperature was 40 ℃.Related substances in 3 batches of samples were determined.RESULTS: Hydrocodone bitartrate was completely separated from related substances.The calibration curve of hydrocodone bitartrate was linear within 1.020 5~ 20.410 0 μg·mL-1(r=0.999 7).The linear ranges were 0.508 5~20.340 μg·mL-1 for thebaine(r=0.999 9) and 0.10~40.00 μg·mL-1 for benzophenone(r=1.000 0).The limits of detection were 0.05 μg for hydrocodone bitartrate and 0.005 μg for thebaine and benzophenone.Known impurity peak hadn't been detected in 3 batches of samples.CONCLUSION: The method is simple,selective and sensitive for the determination of related substances in hydrocodone bitartrate raw material.
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