高效液相色谱法检测西药制品中甲醛残留的 方法研究

目的针对西药制品建立一种基于高效液相色谱(HPLC)的甲醛残留检测方法。方法西药中甲醛经2,4-二硝基苯肼衍生化得到2,4-二硝基苯腙后,采用高效液相色谱进行分析,以乙腈-水(60:40,V:V)为流动相进行等度洗脱。并对高效液相色谱条件进行优化。考察所建方法的线性关系、检出限、精密度、回收率、专属性、耐用性、样品及标准溶液的稳定性。结果甲醛在2.38~14.28 mg/L内呈现良好的线性关系,回收率为92.21%,相对标准偏差(RSD)为1.897%。结论该方法具有较强的专属性和耐用性,可用于西药制品中甲醛残留的实际检测。

Determination of formaldehyde residues in medicine by high performance liquid chromatography

Objective :A method base on High Performance Liquid Chromatography(HPLC) has been developed for the determination of formaldehyde in medicine which was derivatized by 2,4-dinitrobenzene hydrazine solution. Methods: 2,4-dinitrobenzene hydrazine solution was used for sample dramatization, the mobile phase was acetonitrile-water(60/40). In the study, we compared the influence of different chromatographic conditions on the separation effect of formaldehyde, and studied the linearity, the limits of detections (LODs), precision, recovery, specificity, durability and the stability of samples and standard solutions. Results: Formaldehyde concentration(2.38-9.52 mg/L) showed a good linear relationship with peak area. The recoveries of this method was 92.23%, and RSD was 1.894%. Conclusion: this method exhibited strong specificity and durability, and it could be used for the determination of the residual amount of formaldehyde in medicine (hydrochloric acid).