Determination of the Related Substances in Ketamine Hydrochloride by HPLC

OBJECTIVE To establish an HPLC method for determination of the related substances in ketamine hydrochloride.METHODS Waters Xbridge C₁₈ column was used; the mobile phase A consisted of 0.005 mol·L^-1 sodium hexanesulfonate aqueous solution-acetonitrile-phosphoric acid (90︰10︰0.1), the mobile phase B was acetonitrile, with gradient elution at the flow rate of 1.0 mL·min^-1; the detection wavelength was 215 nm; the column temperature was 30℃. RESULTS The minimum separation between the main component and each impurity was >1.5; ketamine and its six impurities showed a good linear relationship in the self-concentration range (r>0.999); and the average recoveries were 97.6%-103.0% with RSDs of 0.8%-2.8%. CONCLUSION The method is accurate, sensitive and reliable, which is suitable for the determination of related substances in ketamine hydrochloride.