高效液相色谱法测定头孢氨苄甲氧苄啶胶囊的含量均匀度

Determination of Content Uniformity of Cefalexin and Trimethoprin Capsules by HPLC

目的建立头孢氨苄甲氧苄啶胶囊含量均匀度的测定方法。方法以0.025 mol/L磷酸溶液(用20%氢氧化钠调节pH至3.0)-乙腈(85∶15)为流动相,流速1 mL/min,检测波长235 nm,用高效液相色谱法测定含量。结果头孢氨苄质量浓度在12.5～125μg/mL、甲氧苄啶质量浓度在2.5～25μg/mL范围内与峰面积线性关系良好,平均回收率分别为99.9%和99.8%,RSD分别为0.38%和0.95%(n=9)。结论所用方法简便快捷,能准确地测定产品的含量均匀度,可用于头孢氨苄甲氧苄啶胶囊的质量控制。

Objective To establish a method to determine the content uniformity of Cefalxin and Trimethoprin Capsules.Methods The HPLC method was adopted.0.025 mol/L phosphoric acid（adjusting pH to 3.0 with 20% sodium hydroxide）-acetonitrile（85 ∶ 15） was used as the mobile phase with flow rate of 1 mL/min,and the detection wavelength at 235 nm.Results There was a good linearity of cefalexin within the range of 12.5-125 μg/mL（r = 0.999 99） and trimethoprin within the range of 2.5-25 μg/mL.The average recovery rate was 99.9%（RSD = 0.38%） and 99.8%（RSD = 0.95%） respectively.Conclusion This method is convenient,simple,quick and reproducible,which can quantitatively determine the content uniformity of Cefalxin and Trimethoprin Capsules and is suitable for the quality control of Cefalxin and Trimethoprin Capsules.