洛汀烟酸缓释片中两组分的含量测定

Determination of Lovastain and Nicotinic Acid in Compound Lovastatin-Nicotinic Acid Sustained-Release Tablets

目的建立复方洛汀烟酸缓释片中洛伐他汀和烟酸的含量测定方法。方法采用高效液相色谱(HPLC)法,色谱柱为ODS柱(250mm×4.6mm,5μm)&流动相为水-乙腈-四丁基氢氧化铵(80.5∶18∶1.5);检测波长为263nm;流速为1.0mL/min;进样量为20μL。结果洛伐他汀和烟酸的质量浓度线性范围分别为25～150μg/mL和25～250μg/mL,平均回收率分别为100.1%和99.22%,RSD分别为1.5%和1.37%。结论HPLC法准确可靠,简单可行,可用于复方洛汀烟酸缓释片的质量控制。

Objective To establish the determination method of lovastatin and nicotinic acid in Compound Lovastatin - Nicotinic Acid Sustainde - Release Tablet. Methods ODS column （250 mm × 4.6 mm, 5μm） with water - acetonitrile - tetrabutyl ammonium hydroxide （80. 5 ： 18 ： 1, 5） as the mobile phase was used. The wavelength was at 265 nm and the flow rate was 1.0 mL/min. Results The lovastatin and nicotinic acid curves were linear at the ranges of 25 - 150 μg/mL and 25 - 250 μg/mL. The average recovery rates were 100. 1% with RSD 1.5% for lovastatin and 99.22% with RSD 1.37% for nicotinic acid. Conclusion This method is reliable and simple. It can be used for the quality control of Compound Lovastatin- Nicotnic Acid Sustained- Release Tablet.