HPLC法同时测定复方氨酚葡锌片中对乙酰氨基酚和盐酸二氧丙嗪的含量

Simultaneous Content Determination of Paracetamol and Dioxopromethazine Hydrochloride in Compound Paracetamol and Zinc Gluconat Tablets by HPLC

目的:建立以高效液相色谱法同时测定复方氨酚葡锌片中对乙酰氨基酚和盐酸二氧丙嗪含量的方法。方法:色谱柱为Sinochrom ODS-BP,流动相为0.04mol·L-1KH2PO4(pH2.60,含0.40%三乙胺)-乙腈(75∶25),流速为1.0mL·min-1,检测波长为264nm,柱温为室温,进样量为20μL。结果:对乙酰氨基酚和盐酸二氧丙嗪检测浓度的线性范围分别为2.818×10-3～3.605×10-1mmol·L-1、1.118×10-4～1.431×10-2mmol·L-1,回收率均大于99.2%,日内RSD均<1.82%,日间RSD均<1.90%。结论:本方法快速、简便、准确,可用于该制剂的含量测定。

OBJECTIVE： To establish a HPLC method for simultaneous determination of paracetamol and dioxopromet-hazine hydrochloride in compound paracetamol and zinc gluconat tablets. METHODS： The determination was performed on Sinochrom ODS- BP column with the mobile phase consisting of 0.04 molcL^-1 KH2PO4（pH = 2.60, 0.40% triethylamine） - acetonitril（75 ： 25） at a flow rate of 1.0 mL·min^-1; the detection wavelength was set at 264 nm; the column was maintained at room temperature and the sample size was 20μL. RESULTS： The calibration curve was linear over the range of 2.818×10^-3—3.605×10^-1mmol·L^-1 for paracetamol and 1.118×10^-4—1.431×10^-2mmol·L^-1 for dioxopromethazine hydrochlo-ride. The recovery rates of both were greater than 99.2%. The intra-day RSDs of both were less than 1.82% and the be-tween-day RSDs of both were less than 1.90%. CONCLUSION： The method is rapid, simple and accurate, and it is applicable for the quality control of the tablets.