高效液相色谱法测定头孢地尼有关物质

Determination of related substances in cefdinir by HPLC assay

目的：建立高效液相色谱法测定头孢地尼的有关物质。方法：采用迪马ODS（150mm×4．6mm，5um）色谱柱；流动相：A[0．25％四甲基氢氧化铵溶液（用10％磷酸溶液调节pH值至5．5）1000ml，加入0．1mol／L乙二胺四醋酸二钠0．4ml]，B[0．25％四甲基氢氧化铵溶液（用10％磷酸溶液调节pH值至5．5）-乙腈-甲醇（500：300：200），加入0．1mol／L乙二胺四醋酸二钠0．4ml]进行梯度洗脱；流速为0．9ml／min；检测波长为254nm；柱温为40℃。结果：头孢地尼线性范围为7．64-76．40ug/ml（r=0．9999）。结论：该方法准确可靠，可控制头孢地尼的有关物质。

OBJECTTIVE To establish a HPLC assay for determining related substances in cefdinir. METHODS Dikma C18 column（ 150 mm × 6 mm, 5 um）was used. The mobile phase was A [ 0.25% Tetramethylammonium Hydroxide in 1 000 ml water and adjusted to pH 5.5 with 10% phosphoric acid and 0.1 mol/L Disodium Edetate 0.04 ml was added] and B[ 0.25% Tetramethylammonium Hydroxide in 1 000 ml water and adjusted to pH 5.5 with 10% phosphoric acid ： Acetonitrile： Methanol { 500：300 ： 200） and 0.1 mol/L Disodium Edetate 0.04 ml was added] elution linear gradient;The detection wavelength was at 254 nm; Temperature was 40 ℃. RESULTS The linear ranges were 7.64 - 76.40 ug/ml （ r = 0. 999 9 ）. CONCLUSION The method is accurate, credibile. It can be used as quality control for related substances in cefdinir.