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目的:建立HPLC梯度法测定氯替泼诺妥布霉素复方混悬滴眼液中氯替泼诺含量及有关物质。方法:采用HPLC法,色谱柱:Inertsil ph苯基柱(250 mm×4.6 mm,5μm);流动相A:0.25%醋酸溶液-乙腈(80∶20);流动相B:乙腈;流速:2.0ml·min-1,进行线性梯度洗脱;检测波长:244 nm;柱温:30℃;进样量:20μl。结果:主成分与各杂质峰分离度良好。氯替泼诺浓度在0.001~1.02 mg·ml-1(r=0.999 9)范围内与峰面积线性关系良好,平均回收率为99.9%,RSD为0.9%(n=9)。结论:该方法灵敏准确,色谱峰分离完全,可用于氯替泼诺妥布霉素混悬滴眼液的质量控制。
OBJECTIVE: To establish a HPLC gradient method for the determination of loteprednol etanercept and its related substances in loteprednol eptifibatide suspension. Methods: The HPLC method was adopted. Column was Inertsil ph phenyl column (250 mm × 4.6 mm, 5 μm); mobile phase A was consisted of 0.25% acetic acid and acetonitrile (80:20); mobile phase B Min-1, linear gradient elution; detection wavelength: 244 nm; column temperature: 30 ℃; injection volume: 20μl. Results: The main components and impurity peaks separated well. The linear relationship between the concentration of loteprednol eofe and the peak area in the range of 0.001 ~ 1.02 mg · ml-1 (r = 0.999 9) was good with an average recovery of 99.9% and a RSD of 0.9% (n = 9). Conclusion: The method is sensitive and accurate, the chromatographic peaks are completely separated and can be used for the quality control of loteprednol eudovidil suspension eye drops.