高效液相色谱法同时测定镇痛凝胶剂中氯胺酮和咪唑安定含量

Simultaneous Determination of Ketamine and Midazolam in Zhengtong Gels by HPLC

目的建立同时测定镇痛凝胶剂中氯胺酮和咪唑安定含量的高效液相色谱(HPLC)法。方法采用RP-HPLC外标法,色谱柱为Hypersil C18柱(250 mm×4.6 mm,5μg),流动相为乙腈-甲醇-0.01%三乙胺(33∶45∶22,V∶V∶V),流速为0.8 m L/min,柱温为25℃,检测波长为220 nm。结果氯胺酮和咪唑安定的进样质量浓度线性范围分别为24.32~243.2μg/m L(r=0.999 2)和20.28~202.8μg/m L(r=0.999 6),日内及日间精密度的RSD均小于10%,平均回收率分别为97.78%和100.49%。结论该方法快捷方便、结果可靠,可作为镇痛凝胶剂的质量控制方法。

Objective To establish an HPLC method to simultaneously determine ketamine and midazolam in Zhengtong Gels. Methods The separation was carried out on a Hypersil C18 column ( 250 mm × 4. 6 mm,5 μm ) with a mobile phase of acetonitrile-methanol-0. 01% triethylamine(33:45:22, V: V: V). The detection wavelength was 220 nm, the flow rate was 0. 8 mL/min and the column temperature was 25 ℃. Results The linear range of ketamine and midazolam were 24. 32-243. 2 μg/mL ( r=0. 999 2 ) , 20. 28-202. 8 μg/mL ( r=0. 999 6 ) , respectively. The inter-day and intra-day precision( RSD)were both less than 10%. The average recovery ( n=9 ) were 97. 78% and 100. 49%, respectively. Conclusion The method is simple, rapid, sensitive and reproducible.