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目的建立TFV·DF测定方法。方法:Alltech混合阴离子交换C8100A7μm色谱柱(250×4.6mm),以0.02mol/L磷酸二氢钾缓冲液(pH6.0)-乙腈(65:35)为流动相,流速为1.0mL/min;检测波长为260nm,柱温为室温。结果TFV.DF质量浓度在1.0～50.0μg/ml范围内与峰面积线性关系良好。RSD为0.43%。结论:HPLC法灵敏、简便、准确、重现性好,能满足质量控制要求。
Objective To establish a method for the determination of TFV and DF. METHODS: Alltech mixed anion exchange C8100A7μm column (250 × 4.6mm) was used with a mobile phase of 0.02mol / L potassium phosphate buffer (pH6.0) - acetonitrile (65:35) at a flow rate of 1.0mL / min. Detection wavelength was 260nm, the column temperature was room temperature. Results TFV.DF had a good linear relationship with the peak area in the range of 1.0-50.0 μg / ml. RSD was 0.43%. Conclusion: HPLC method is sensitive, simple, accurate and reproducible, which can meet the quality control requirements.