HPLC法测定氟哌啶醇片中主药的含量

Content Determination of Main Compontents in Haloperidol Tablets by HPLC

目的:建立以高效液相色谱法测定氟哌啶醇片中主药含量的方法。方法:色谱柱为Diamonsil C18,流动相为0.1mol·L-1磷酸二氢钾(pH3.0)-甲醇(45∶55),流速为1.0mL·min-1,检测波长为248nm,柱温为35℃,进样量为20μL。结果:氟哌啶醇检测浓度的线性范围为0.01～1mg·mL-1(r=0.9999);平均回收率为97.6%(RSD=1.1%)。结论:本方法简便、快速、准确、专属性好,可用于该制剂的质量控制。

OBJECTIVE： To develop an HPLC method for determination of the content of the main compontents in haloperidol tablets. METHODS： The samples were determined on Diamonsil C18 column at a column temperature of 35 ℃. The mobile phase consisted of 0.1 mol·L^-1 KA-IPO4 （pH 3.0） -methanol （45 ： 55） at a flow rate of 1.0 mL·min ^-1. The UV detection wavelength was 248nm and the sample size was 20uL. RESULTS： The linear range for haloperidol was 0.01-1 mg·mL^-2 （r = 0.999 9） and its average recovery was 97.6% （RSD = 1.1% ） . CONCLUSIONS： The method was simple, rapid, accurate and specific, and suitable for the quality control of this preparation.