RP-HPLC法测定复方辛伐他汀烟酸缓释片中辛伐他汀的含量  

Determination of Simvastatin in Niacin Extended-Release / Simvastatin Tablets by RP-HPLC

作　　者：吴娟娟[1] 沙景阳[1] 沈卫阳[1] 

机构地区：[1]中国药科大学理学院,药物质量与安全预警教育部重点实验室,南京210009

出　　处：《海峡药学》2013年第8期58-60,共3页Strait Pharmaceutical Journal

摘　　要：目的采用RP-HPLC法,建立复方辛伐他汀烟酸缓释片中辛伐他汀含量的测定方法。方法色谱条件:Welch-C18色谱柱(4.6mm×33mm,3μm),以乙腈-0.1%磷酸溶液(50∶50)为流动相A,0.1%磷酸的乙腈溶液为流动相B进行梯度洗脱,流速为3.0mL·min-1;检测波长为238nm。结果辛伐他汀在19.99～999.6μg·mL-1范围内线性关系良好(r=0.9999),平均回收率为99.7%,(RSD=0.45%),定量限为27ng。结论该方法简单易操作,准确度好,专属性强,可用于辛伐他汀的含量测定。OBJECTIVE To establish a RP-HPLC method for the determination of simvastatin in Niacin Extended-Release/Simvastafin Tablets. METHODS The analysis was performed on a Welch-C18 （4. 6mm × 33mm,31μm） colunm with acetonitrile-O.1% phosphate solution （50：50） as mobile phase A and 0. 1% of phosphate acetonitrile solution as mobile phase B for gradient clution. The flow rate was 3. 0mL · min ^-1, The detection wavelength was set at 238nm. The column Temperature was 30℃. RESULTS This method has been validated under various conditions. Simvastatin had a good linear relationship within the range of 19.99 ~ 999. 6 mL · min ^-1 （ r = 0. 9999 ）. The average recovery was 99. 7% （ RSD = 0. 45% ）, and the LOQ is 27ng. CONCLUSION This method is accurate, specific and can be used to determine the contents of simvastatin.

关 键 词：RP-HPLC 辛伐他汀 含量测定 复方辛伐他汀烟酸缓释片 

分 类 号：R927.2[医药卫生—药学]