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

摘要: 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。

Abstract: 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.