高效液相色谱法测定碘化N-正丁基氟哌啶醇含量

Determination of N-n-butyl haloperidol iodide by HPLC

目的:用高效液相色谱法测定碘化N-正丁基氟哌啶醇 (F 2 )的含量.方法:采用Phenomenex Luna C 18 反相色谱柱( 4.6 mm×250 mm,5 μm),以乙腈-甲醇-0.025 mol·L -1 磷酸二氢钾(45∶5∶50)作为流动相,流速为 0.8 mL·min -1 ,检测波长:248 nm,柱温:35 ℃,进样体积:20 μL,按外标法以峰面积计算F 2 的含量.结果:F 2 在1～10 mg·L -1 浓度范围内,浓度与峰面积的线性关系良好,r为 0.999 2 ,RSD为 1.70% (n=5).结论:本方法简便,快速,结果准确,可靠,重现性好,可用于本品质量控制.

OBJECTIVE To establish an HPLC method for the determination of N-n-butyl haloperidol iodide（F2）. MEWHODS The separation was performed on a Phenomenex Luna C18 column（ 4. 6 mm × 251） mm, 5 μm） with CH3CN-CH3OH-0. 025 mg·L^-1 KH2PO4 （45：5：50） as mobile phase. The flow rate was 0. 8 mL·min^-1, the detection was set at 248 nm and the column temperature was maintained at 35 ℃. RESULTS The calibration curve was linear in the concentration range of 1 - 10 mg·L^-1, r = 0. 999 2. CONCLUSION The method is simple, rapid, accurate and reproducible. It may be adopted for quality control of this drug.