洛伐他汀胶囊质量控制的高效液相色谱方法

Quality Control of Lovastatin Capsule by HPLC

利用高效液相色谱法(HPLC)建立洛伐他汀胶囊质量控制方法.采用VP-ODS(150 mm×4.6 mmi.d)柱,流动相为V(甲醇)∶V(磷酸缓冲溶液(pH=4.0))=78∶22,流速1.0 mL/min,检测波长238 nm,进样体积10μL,柱温为室温.洛伐他汀在0.004～1.000 g/L内,峰面积与质量浓度呈良好线性关系(r=0.999 9),平均回收率99.19%(n=9),方法精密度RSD为0.32%(n=6),最小检出限3 ng.该方法简单,准确,重现性好,可应用于洛伐他汀胶囊的质量控制.

The quality control method was established by determinating the content and related substance of lovastatin capsule by HPLC. The VP-ODS（150 mm×4.6 mm i. d）column was used and the mo- bile phase was consisted of V（methanol） ： V（pH= 4. 0 phosphate） =78 ： 22, the flow rate was 1.0 mL/min, the detective wavelength was 238 nm, the injiection volumn was 10μL, the column temperature was room temperature. A good linearity（r =0. 999 9） was obtained in the concentration range of 0. 004-1. 000 g/L, and the average recovery of lovastatin was 99.19%（n=9）. The method precision was 0.32% （n= 6）, and the lowest examination limits was 3 ng. The method is simple, accurate and reproducible. It can be applied for the quality control of lovastatin capsule.