高效液相色谱法检测西药制品中甲醛残留的 方法研究

Determination of formaldehyde residues in medicine by high performance liquid chromatography

中文关键词:  甲醛  高效液相色谱  西药制品

英文关键词:formaldehyde  high performance liquid chromatography  medicine

中文摘要:

      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。

英文摘要:

      Objective To establish a method for determination of formaldehyde residues in medicine by high performance liquid chromatography (HPLC). Methods Formaldehyde in medicine reacted with 2,4-dinitrobenzenehydrazine to form 2,4-dinitrobenzenehydrazone, which was analyzed by high performance liquid chromatography with acetonitrile-water(60:40, V:V) as the mobile phase. Conditions for sample analysis by HPLC were optimized. The linearity, limits of detections (LODs), precision, recovery, specificity, durability and stability of sample and standard solutions were studied. Results This analytical method showed a good linear relationship which was 2.38~14.28 mg/L. The recovery and relative standard deviation (RSD) was 92.21% and 1.897%, respectively. Conclusion The test result demonstrated that this analytical method exhibits strong specificity and durability, and it can meet the requirement for the formaldehyde residual in medicine.