反相高效液相色谱法测定盐酸头孢他美酯片含量

Content Determination of Cefetamet Pivoxil Hydrochloride in Cefetamet Pivoxil Hydrochloride Tablets by RP-HPLC

目的建立测定盐酸头孢他美酯片中盐酸头孢他美酯含量的高效液相色谱法。方法采用反相高效液相色谱（RP-HPLC）法,色谱柱为Hypersil C18柱（200 mm×4.6 mm,10μm）,以乙腈-2 mmol/L高氯酸（20∶80）为流动相,检测波长为265 nm,流速为1.0 m L/min。结果盐酸头孢他美酯质量浓度在10.0~80.0μg/m L范围内与峰面积线性关系良好,高、中、低质量浓度的平均加样回收率为99.35%,RSD为1.23%（n=6）。结论该方法准确、简便,适用于盐酸头孢他美酯片的质量控制。

Objective To establish a reversed phase high- performance liquid chromatography（RP- HPLC） method for determining the cefetamet pivoxil hydrochloride content in Cefetamet Pivoxil Hydrochloride Tablets. Methods The RP-HPLC method was adopted with the Hypersil C18 column（200 mm ×4.6 mm,10 μm） and the mobile phase of acetonitrile-2 mmol/L perchloric acid solution（20 ： 80）. The UV detection wavelength was 265 nm and the flow rate was 1.0 mL/min. Results The eoneentration of cefetamet pivoxil hy- drochloride within the range of 10. 0-80.0 μg/mL showed a good linear with the peak area（ r =0. 999 9）,the average recovery rates of high, middle and low concentrations was 99.35%, RSD was 1.23% （n =6）. Conclusion This method is simple,accurate, effective and suitable for the quality control for Cefetamet Pivoxil Hydrochloride Tablets.