摘要
目的建立辛伐他汀分散片含量测定及有关物质的检查方法。方法采用Supelco C18柱(33 mm×4.6 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,流速为3.0 mL/min,检测波长为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,辛伐他汀质量浓度在20.02~180.2μg/mL范围内与峰面积呈良好的线性关系,回归方程A=12 493 C+2 199,r=0.999 9(n=7);日内精密度RSD为0.59%(n=6);日间精密度RSD为0.69%(n=6);平均回收率为99.9%,RSD=0.51%(n=9);供试品溶液在6 h内基本稳定;检测限为17.26 ng/mL。结论该方法专属性强、灵敏度高,可用于辛伐他汀分散片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 Dispersible Tablets. Methods The Supelco C^s column （33 mmx4.6 mm,3 ~m） was adopted with acetonitrile-0. 1% phosphoric acid solution （50：50） as the mobile phase A and 0.1% phosphoric acid acetonitrile solution as the mobile phase B, by the gradient elution. The flow rate was 3.0 mL/min and the detection wavelength was 238 nm. Results Simvastatin, simvastatin acid,lovastatin and the degradation products generated by force destroy were separated well. The mass concentration of simvastatin in the range of 20. 02- 180. 2μg/mL revealed the good linear relation with the peak area. The regression equation was A = 12 493 C ＋ 2 199 （r = 0. 999 9, n =7）. The intra- day precision（RSD） was 0. 59% （n=6） and inter-day precision（RSD） was 0.69% （n =6）;the average recovery rate was 99.9%, RSD = 0. 51% （n =9）;the test sample solution was basically stable within 6 h;the limit of detection was 17.26 ng/mL. Conclusion This method has strong specificity and high sensitivity, and can be used for the content determination of of Simvastatin Dispersible Tablets and the detection of related substances.
出处
《中国药业》
CAS
2013年第18期52-54,共3页
China Pharmaceuticals
