HPLC法测定辛伐他汀滴丸的含量和有关物质  

HPLC Determination of Content and the Related Substances of Simvastatin Pills

作　　者：郑金琪[1] 俞雄杰[2] 郑国钢[1] 李会林[1] 

机构地区：[1]浙江省食品药品检验所,杭州310004 [2]中国药科大学药学院,南京210009

出　　处：《中国药品标准》2012年第6期418-422,共5页Drug Standards of China

摘　　要：目的:建立辛伐他汀滴丸含量测定及有关物质的检查方法。方法:采用反相高效液相色谱法,色谱柱为SUPELCO C18柱(4.6 mm×33 mm,3μm),以乙腈-0.1%磷酸(50∶50)为流动相A,0.1%磷酸乙腈溶液为流动相B,梯度洗脱,流量3.0 mL.min-1,检测波长238 nm。结果:辛伐他汀与辛伐他汀酸、洛伐他汀及强制破坏产生的降解产物均分离良好,辛伐他汀浓度在20.94～188.5μg.mL-1范围内,与峰面积呈良好的线性关系,回归方程A=9 414.7C+7 327.2,r=1.000(n=7);平均回收率为99.8%,RSD为0.77%(n=9)。结论:该法专属性强,准确、灵敏,可用于辛伐他汀滴丸的含量测定和有关物质检查。Objective： To establish a method to determine the content and related substances of Simvastatin Pills. Methods： HPLC was used and chromatography condition was determined. The system was carried out using SUPELCO Cls column （4. 6 mm × 33 mm, 3 um）and acetonitrile -0.1% phosphoric acid solution （50： 50） as the mobile phase A, 0.1% phosphoric acid in acetonitrile as the mobile phase B, gradient elution. The flow rate was 3.0 mL · min-1 and the detection wavelength was 238 nm. Results： The resolution between the peak of Losvatatin and Simvastatin was above 4. 0 and that between the peak of Losvatatin and Simvastatin acid was above 1.5 and the main peak could be separated from all peaks of degradation products. The linear range of the method was 20. 94-188. 5 ug · mL-1 and the regression equation was A =9 414. 7C ＋7 327. 2,r = 1. 000（n =7）. The average recovery was 99. 8% （RSD =0. 77% ,n =9） and the limit of detection was 60. 08 ng · mL-1. The sample solution was stable within 24 hours. Conclusion： The method is specific, accurate, sensitive and can be used for the determination of content and related substances of Simvastatin Pills.

关 键 词：辛伐他汀滴丸 含量测定 有关物质 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]