论文部分内容阅读
目的建立洛伐他汀及片剂有关物质的HPLC测定方法,同时考察了13批洛伐他汀原料及12批洛伐他汀片剂的有关物质。方法使用Xterra C18柱(4.6mm×250mm,5μm),以乙腈-0.01%磷酸(60∶40)为流动相采用线性梯度表洗脱,流速为1.0mL·min-1,检测波长为238nm。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0.25ng。结论方法准确、灵敏度高,本方法可有效地控制药品质量。
OBJECTIVE To establish a HPLC method for the determination of lovastatin and its related substances, and to investigate the related substances of lovastatin raw materials and 12 lovastatin tablets. Methods A linear gradient elution was performed on a Xterra C18 column (4.6 mm × 250 mm, 5 μm) using a mobile phase of acetonitrile-0.01% phosphoric acid (60:40) at a flow rate of 1.0 mL · min -1 and a detection wavelength of 238 nm. Results The lovastatin chromatographic retention time was about 15min, and its related substances were well separated. The detection limit of lovastatin was 0.25ng. Conclusion The method is accurate and sensitive, this method can effectively control the quality of medicines.