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目的:采用HPLC法测定盐酸埃克替尼乳膏含量及有关物质。方法:含量测定采用Grace C18色谱柱(250 mm×4.6 mm,5μm),流动相为0.02 mol·L-1磷酸二氢钠溶液-乙腈(50∶50),流速为1.0 m L·min-1,检测波长为334 nm。有关物质检测采用Grace C18色谱柱(250 mm×4.6 mm,5μm),0.1 mol·L-1磷酸二氢钠溶液-乙腈(60∶40)为流动相,检测波长为246 nm,流速为1.0 m L·min-1。结果:盐酸埃克替尼在4.01~40.10μg·m L-1范围内具有良好的线性关系(A=51 863C-11 321,r2=0.999 7),重复性良好(RSD=1.46%)。进样精密度、重复性良好。平均回收率为99.15%,RSD值为0.58%。空白辅料不干扰检测,盐酸埃克替尼与相关杂质之间的分离度良好。结论:本方法可以方便、快速、准确地检测盐酸埃克替尼乳膏的含量及其有关物质。
Objective: To determine the content of Icotinib hydrochloride cream and its related substances by HPLC. Methods: The determination of the content was carried out on a Grace C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of 0.02 mol·L-1 sodium dihydrogen phosphate-acetonitrile (50:50) at a flow rate of 1.0 mL · min -1 , Detection wavelength of 334 nm. The related substances were detected on a Grace C18 column (250 mm × 4.6 mm, 5 μm) with 0.1 mol·L-1 sodium dihydrogen phosphate solution-acetonitrile (60:40) as the mobile phase at a detection wavelength of 246 nm and a flow rate of 1.0 m L · min-1. RESULTS: Icitinib hydrochloride had a good linearity (A = 51 863C-11321, r2 = 0.999 7) with good reproducibility (RSD = 1.46%) in the range of 4.01-40.10μg · m L-1. Injection precision, good reproducibility. The average recovery was 99.15% with a RSD value of 0.58%. Blank adjuvant does not interfere with the detection, the separation between the Icotinib hydrochloride and related impurities is good. Conclusion: This method can be convenient, rapid and accurate detection of the content of Icotinib hydrochloride cream and its related substances.