HPLC测定盐酸氯胺酮原料药中的有关物质

Determination of the Related Substances in Ketamine Hydrochloride by HPLC

目的建立HPLC检测盐酸氯胺酮原料药中有关物质的方法。方法采用Waters Xbridge C18色谱柱,以0.005 mol·L^(-1)己烷磺酸钠水溶液-乙腈-磷酸(90︰10︰0.1)为流动相A,乙腈为流动相B,梯度洗脱,流速1.0 mL·min^(-1),检测波长215 nm,柱温30℃。结果主成分与各杂质间最小分离度>1.5;主成分以及其6个杂质在各自的浓度范围内呈良好的线性关系(r>0.999);平均回收率为97.6%~103.0%,RSD为0.8%~2.8%。结论本方法准确、灵敏、可靠,适用于盐酸氯胺酮有关物质的测定。

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.