高效液相色谱法测定诺氟沙星胶囊含量

Determination of the content of Norfloxacin capsule by an HPLC method

目的：建立诺氟沙星胶囊含量的高效液相色谱测定方法。方法： Nova- pak C 18钢柱，流动相为 0. 025 mol／ L磷酸 (三乙胺调节 pH至 3. 1)∶乙晴 =87∶ 13，紫外检测波长 278 nm，流速 0. 8 ml／ min。结果：诺氟沙星和内标的出峰时间分别为 5. 40和 6. 40分。在 2. 5～ 25． 0 mg／ L范围内线性良好， r=0． 9996，日内变异系数为 0. 72％，平均回收率为 99. 80％， RSD为 0. 79％。测定 4批诺氟沙星胶囊含量在 95. 77％～ 98． 74％。结论：该方法快速，准确，灵敏，特异性强，回收率高，适于药品质量控制。

Objective:To establish an HPLC method for determining the content of norfloxacin capsule.Method:Au- Novapak C18 column was used.The mobile phase consists of 87％ 0.025 mol/L phosphate acid (pH was adjusted to 3.1 by triethylamine)and 13％ acetonitrile.UV was 278 nm and the flow rate was 0.8ml/min.Result:The rentention time of Norfloxacin and internal standard was 5.40 and 6.40 min respectively.A good linearity was obtained in the concentration range of 2.5～ 25.0 mg/L with correlation coefficient 0.9996,the RSD with- in day was 0.72％ ,the average recovery was 99.80％ ,RSD was 0.79％ .The contents of 4 batches of norfloxacin capsule were 95.77％～ 98.74％ .Conclusion:This method was rapid,precision and sensitive with high specificity and recovery.It was good for drug quality control.