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目的:建立洛伐他汀有关物质的HPLC测定方法,同时考察了8个厂家13批洛伐他汀原料的有关物质。方法:使用Xterra C18柱(4.6 mm×250 mm,5μm),以乙腈-0.01%磷酸溶液(60∶40)为流动相梯度洗脱,流速为1.0 mL.min-1,检测波长为238 nm。结果:洛伐他汀色谱保留时间约为15min,与其有关物质分离良好,洛伐他汀的检测限为0.25 ng。结论:方法准确,灵敏度高,可有效地控制药品质量。
OBJECTIVE: To establish a method for the determination of lovastatin-related substances by HPLC and to examine the related substances of 13 lovastatin raw materials from 8 manufacturers. METHODS: The mobile phase was eluted with a gradient of acetonitrile-0.01% phosphoric acid (60:40) on a Xterra C18 column (4.6 mm × 250 mm, 5 μm) at a flow rate of 1.0 mL.min-1 with a detection wavelength of 238 nm. Results: Lovastatin chromatographic retention time of about 15min, and its related substances isolated well, lovastatin limit of detection of 0.25 ng. Conclusion: The method is accurate, sensitive and can effectively control the quality of medicines.