HPLC检测盐酸文拉法辛中的甲醛  

Determination of formaldehyde in Venlafaxine hydrochloride by HPLC

作　　者：宋光华[1] 白菊 张梅丽 蔡成英 严莉容 杨贵 刘芙蓉 柯潇[1] SONG Guanghua;BAI Ju;ZHANG Meili;CAI Chengying;YAN Lirong;YANG Gui;LIU Furong;KE Xiao(Therapeutic Proteins Key Laboratory of Sichuan Province,Chengdu Konghong Pharmaceutical Group Co.,Ltd.,Chengdu,Sichuan 610036 P.R.China)

机构地区：[1]成都康弘药业集团股份有限公司生物大分子蛋白药物四川省重点实验室

出　　处：《华西药学杂志》2018年第4期404-405,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法定量检查盐酸文拉法辛中低浓度的甲醛。方法盐酸文拉法辛中残留的甲醛与2，4-二硝基苯肼生成具有强紫外吸收的衍生物，通过HPLC检查该衍生物的含量，从而检查甲醛的含量。结果甲醛衍生物检查方法的专属性、精密度、准确性、线性和耐用性均符合检测要求，S／N=3：1时，甲醛的最低检测限为0．16ng，在限度浓度50％、100％和150％条件下的平均回收率为96．80％，16—80ng·mL^-1甲醛浓度与峰面积呈良好的线性关系（r=0．9999），色谱条件和衍生化反应条件的耐用性均良好。结论所用方法可用于盐酸文拉法辛中低含量甲醛的定量检测。OBJECTIVE To determine the low consentration formaldehyde in Venlafaxine hydrochloride by HPLC. METHODS HCHO -2,4 -dinitrophenylhydrazine （DNPH） derivatization product reacted with DNPH and formaldehyde in Venlafaxine hydrochloride was detected by HPLC - UV with strong absorption capability in an ultraviolet light region to indicate the quantitation of formaldehyde. RESULTS It demonstrated that the procedure developed was sensitive, accurate, precise, linear and robust. Detection limit was 0.16 ng. The average recovery was 96.80% with formaldehyde at three levels corresponding to 50% , 100% and 150%. The method was linear in the specified range （16-80 ng·mL^-1） with the correlation coefficient of 0. 9999. The stability of derivatization product over a period of 24 h in standard and sample and the robustness of the detection and synthetic methods were demonstrated. CONCLUSION All results are acceptable and confirms that the method is suitable for its intended use.

关 键 词：盐酸文拉法辛 甲醛 衍生化 2 4-二硝基苯肼 检测限 高效液相色谱法 回收率 线性 

分 类 号：R917[医药卫生—药物分析学]