HPLC法测定辛伐他汀片的含量

摘要

Aim To establish an HPLC method for determination of simvastatin in simvastatin tablets. Methods TECHSPHERE ODS column ( 250 mm × 4. 6 mm ,5 μm) was adopted ,with acetonitrile-0. 025 mol· L -1 sodium phosphate monobasic ( pH = 4. 5 ) ( 65 :35 ) as mobile phase. The detector wavelength was set at 238 nm.and the flow rate was 1. 0 ml · min -1. Results Calibration curve was linear over the range of 42.4 ～ 424. 0 mg · L-1 ( r = 0. 999 6) . For potency assay the mean recovery was 99. 6％ with RSD as 1. 24％ ( n = 6) .Conclusion The method is simple ,sensitive and accurate. which was suitable for quantitative detection of simvastatin.%目的 建立一种辛伐他汀片中辛伐他汀含量的HPLC的测定方法.方法 选用Techsphere ODS色谱柱(250 mm×4.6 mm,5 μm),乙腈-0.025% mol·L-1磷酸二氢钠溶液(pH=4.5)(65:35)为流动相,洗脱流速为1.0 ml·min-1,检测波长为238 nm.结果 辛伐他汀在42.4～424.0 mg·L-1浓度范围内线性关系良好(r=0.999 6);平均回收率为99.6%,RSD=1.24%(n=6).结论 该方法简便,灵敏,易行,准确,适用于辛伐他汀的测定.