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目的:采用HPLC法测定丙泊酚注射液的含量及其有关物质。方法:色谱柱为Waters symmetry shieldTM RP18(250mm×4.6mm,5μm),流动相为磷酸盐缓冲液(磷酸二氢钠一水合物2.76g溶解于900ml水中,用85%磷酸调节pH值至3.0,用水稀释至1000ml)-乙腈(35∶65),检测波长为275nm和254nm,流速为1.0ml.min-1,柱温为35℃。结果:标准曲线的线性范围为6.126μg～49.00μg(γ=0.9999);丙泊酚的检测限和定量限分别为0.1ng、0.4ng;丙泊酚与酸、碱、光照、氧化、高温降解产物能够良好的分离。结论:所建方法简便、快速、准确,适用于丙泊酚的含量及有关物质的质量控制。
Objective: To determine the content of propofol injection and its related substances by HPLC. Methods: The column was Waters symmetry shield TM RP18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of phosphate buffer solution (2.76 g sodium dihydrogen phosphate monohydrate was dissolved in 900 ml water, adjusted to pH 3.0 with 85% phosphoric acid, Diluted with water to 1000 ml) -acetonitrile (35:65) at a detection wavelength of 275 nm and 254 nm at a flow rate of 1.0 ml.min-1 and a column temperature of 35 ° C. Results: The linear range of the standard curve was 6.126μg ~ 49.00μg (γ = 0.9999). The limit of detection and the limit of quantification of propofol were 0.1ng and 0.4ng, respectively. Propofol was stable with acid, alkali, light, The product can be well separated. Conclusion: The method is simple, rapid and accurate, suitable for the quality control of propofol and related substances.