摘要
目的：采用高效液相色谱法和紫外分光光度法同时测定注射用赖氨匹林的含量．为质量控制提供有效的分析手段。方法：高效液相色谱法：Hypersil C18（150mm×46mm，10μm），以甲醇－0.1％三乙胺溶液（1：1、冰醋酸调节DH至35）为流动相．检测波长为280nm，按外标法以峰面积计算。紫外分光光度法检测波长210nm。结果：高效液相色谱法：阿司匹林和水杨酸在6034～90510μg／ml和120～1800μg／ml浓度范围内呈良好的线性关系．其线性相关系数分别为09999和09999；加样回收率分别为9876％～9929％（RSD=0.59％～0.93％）；和98．49％～9969％（RSD=O80％～1．01％）。紫外分光光度法赖氨匹林浓度在40～140μg／ml范围内与吸收度有良好的线性关系，回归方程为：Y=0.0548X—0.0299．r=0．9998，方法平均回收率为99.8％～100.7％，RSD为1.62％～1.81％。结论：两种方法均可用作注射用赖氨匹林的质量控制。
Objective： Content determination of simvastatin in simvastatin capsules by HPLC and UV spectrophotoretric methods. Mot.hods： HPLC methods： The eolomm was Hypersil C18（150mm×4.6mm, 10μm）, the mobile phase consists of methane-0.1% triethylamine （1：1, use actic acid glacial pH3.5）, and a detecting wavelength of 280nm,external standard method. UV- spectrophotometr methods： The detecting wavelength of 280nm. Results： HPLC methods： The calibration curves had good linearity in the range of 60.34-905.10μg/ml and 1.20-18.00μg/ml, and the correlation coefficients were 0.9999 and 0.9999 for aspirin and salicylic aicd respectively.The average recovery of aspirin and salicylic acid added were 98.97%- 99.29%（RSD=0.59%- 0.93%） and 98.49%- 99.69%（RSD=0.80%- 1.01%）. UV-spectrophotometr methods： There was a good linearity over the range of 4.0-14.0μg/ml.Yhe linear regression equation is Y=0.0548X-0.0299,r=0.9998. The recovery was 99.8%- 100.7% with RSD of 1.62%- 1.81%. Conclusions： The two methods were simple, repid, accuraate and can be used to control s lysinipirine and its preparations.
出处
《药品评价》
CAS
2011年第12期32-36,共5页
Drug Evaluation
