摘要
目的采用HPLC测定4-羟基苄醇中的有关物质。方法采用DiamonsilC18色谱柱（250mm×4．6mm，5μm），流动相为0．01mol·L^-1磷酸二氢钠（磷酸调pH3．5）-甲醇（65：35），检测波长205nm，流速1．0mL·min^-1，柱温30℃。结果4-羟基苄醇、3-羟基苄醇、2-羟基苄醇、4-羟基苯甲酸的线性范围分别为0．1050～2．100μg·mL^-1（r=0．9999）、0．1042—2．084μg·mL^-1（r=0．9999）、0．1007—2．014μg·mL^-1（r=0．9999）、0．1008～2．016μg·mL^-1（r=0．9999）；检测限分别为0．5080、0．5484、0．6414、0．8640ng。结论所用方法准确、灵敏、快速，适用于4-羟基苄醇中有关物质的检查。
OBJECTIVE To establish an RP - HPLC method for determination of related substances in 4 - hydroxybenzyl alcohol. METHODS Analysis was carried out on a Diamonsil Cl8 column（250 mm× 4.6 mm, 5 μm）using phosphate buffer（0.01 mol· L^-1 NaH2PO4 adjusting pH to 3.5 with phosphoric acid） - methanol（65 ： 35 ）as mobile phase at detective wavelength of 205 nm. The flow rate was 1.0 mL. min-1 and the temperature was 30 ℃. RESULTS The linear ranges of 4 -hydroxybenzyl alcohol ,3 -hydroxybenzyl alcohol ,2 - hydroxybenzyl alcohol and 4 - hydroxybenzoic acid were 0. 1050 - 2. 100μg·mL^-1 （ r = 0. 9999 ） , 0. 1042 - 2. 084μg·mL^-1 （ r = 0. 9999 ）, 0.1007 - 2. 014 μg·mL^-1（ r = 0. 9999 ） and 0. 1008 - 2.016μg·mL^-1 （ r = 0.9999 ）, respectively. The limit of detection was 0. 5080 ng,0.5484 ng,0. 6414 ng and 0. 8640 ng,respeetively. CONCLUSION The method is accurate,sensitive and rapid for quality control of trace impurities in 4 - hydroxybenzyl alcohol.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2014年第1期72-74,共3页
West China Journal of Pharmaceutical Sciences
