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目的:建立HPLC法测定糠酸莫米松乳膏有关物质并对其杂质进行初步确定。方法:采用ZORBAX Eclipse XDB-C_(18)(4.6mm×100mm,3.5μm)色谱柱,以水(A)-乙腈(B)为流动相,梯度洗脱,检测波长254nm,柱温30℃,进样量为50μL,流速2.0mL/min。结果:糠酸莫米松与各杂质、各杂质之间的分离度均良好,糠酸莫米松在0.2~10.0μg/mL浓度范围内与峰面积呈良好的线性关系,回归方程为Y=40.264 6 X+14.742 6(r~2=0.999 8)。结论:此方法能准确定量,可用于糠酸莫米松乳膏的质量控制,并确定了4个特定已知杂质C、D、G和H,其相对保留时间分别为0.88、0.94、0.73和0.56。
OBJECTIVE: To establish a HPLC method for the determination of related substances of mometasone furoate cream and preliminary determination of its impurities. METHODS: The mobile phase was eluted with ZORBAX Eclipse XDB-C 18 column (4.6 mm × 100 mm, 3.5 μm) with gradient elution with water (A) -acetonitrile (B) Injection volume of 50μL, flow rate 2.0mL / min. Results: The separation of mometasone furoate and various impurities and impurities was good. The mometasone furoate showed a good linear relationship with the peak area in the concentration range of 0.2 ~ 10.0 μg / mL, the regression equation was Y = 40.264 6 X + 14.742 6 (r ~ 2 = 0.999 8). CONCLUSION: This method can be accurately quantified and can be used for the quality control of mometasone furoate cream. Four specific known impurities, C, D, G and H, were identified, with relative retention times of 0.88, 0.94, 0.73 and 0.56, respectively .