洛伐他汀烟酸缓释片中洛伐他汀释放度检测研究

Study on Detection of the Lovastatin Dissolution of Sustain-Release Tablet of Niacin and Lovastatin

建立了洛伐他汀烟酸缓释片中洛伐他汀释放度检测方法。取洛伐他汀烟酸缓释片按照《中国药典》洛伐他汀溶出度测定法进行溶出,以0.5%十二烷基硫酸钠磷酸盐缓冲溶液为溶剂,转速为100r·min-1,于45min取样,采用高效液相色谱法测定释放度。色谱条件:以十八烷基硅烷键合硅胶为填充剂,以乙腈-0.5%磷酸溶液(4∶1)为流动相,检测波长238nm,进样量20μL。洛伐他汀浓度在0.59～40.18μg·mL-1范围内与峰面积线性关系良好;回收率在99.0%～101.0%之间,相对标准偏差(RSD)为0.71%。该方法重复性好、稳定性高,适合洛伐他汀烟酸缓释片中洛伐他汀释放度的测定。

The detection of the lovastatin dissolution of sustain-release tablet of niacin and lovastatin was es- tablished. According to the detection method of the lovastatin dissolution in Chinese Pharmacopoeia, the sus- tain-release tablet of niacin and lovastatin was stripped by 0.5% sodium dodecyl sulfate phosphate buffer with rotation speed of 100 r · min-1 , and the lovastain dissolution was measured by HPLC. The chromatographic L conditions were as follows.silica gel octadecylsilanized was the filler,acetonitrile-0.5 % phosphoric acid solution （4 ： 1） was the mobile phase, detection wavelength was 238 nm, injected sample was 20 μL. The results showed,the lovastatin concentration had good linear relation with peak area in the range of 0. 59~40. 18 μg · mL-1. The recovery was 99.0-101.0%. The relative standard deviation（RSD） was 0.71%. This method is suitable for the detection of the lovastatin dissolution of sustain-release tablet of niacin and lovastatin with good repetition and stability.