辛伐他汀咀嚼片中辛伐他汀含量的高效液相色谱测定方法

本文以色谱柱SUPELCOSIL LC-18-DB,33＊4.6 mm,3μm,流速3.0 mL/min,柱温25℃,检测波长238nm,以乙腈-0.1%磷酸（50∶50）和0.1%的磷酸作为流动相。建立一种高效液相色谱测定辛伐他汀咀嚼片中辛伐他汀含量的方法,并对此法进行考察。结果表明辛伐他汀在浓度为0.195 2 mg/mL-0.608 1 mg/mL（浓度水平50%-150%）范围内具有良好的线性,平均回收率为99.3%,RSD为0.64%（n=9）。

Determination of Simvastatin Content in Simvastatin Chewable Tablets by HPLC

In order to establish an assay to determinate simvastatin content in simvastatin chewable tablets by HPLC,a SUPELCOSIL LC-18-DB chromatographic column（33 × 4. 6 mm,3 μm） was adopted for methodology development. The chromatographic condition was as follows： flow rate,3. 0 m L / min; column temperature,25 ℃; detection wavelength,238 nm; mobile phase,0. 1% acetonitrile-phosphate（50 ∶ 50） and0. 1% of phosphoric acid. The results showed that the simvastatin concentration was linear between 0. 195 2mg / m L and 0. 608 1 mg / m L. The mean recovery rate was 99. 3% with RSD as 0. 64%（n = 6）. The method is reliable and accurate,which is suitable for quantitative detection of simvastatin content in simvastatin chewable tablets.