摘要
目的建立测定降脂颗粒中的虎杖苷、二苯乙烯苷、橙皮苷含量的高效液相色谱法。方法色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(20∶80),检测波长283 nm、320 nm,柱温30℃,流速1.0 m L/min。结果虎杖苷质量浓度在5.12~38.40μg/m L范围内与峰面积有良好线性关系(r=1.000),平均回收率为100.13%,RSD为0.63%(n=6);二苯乙烯苷质量浓度在1.91~19.09μg/m L范围内与峰面积有良好线性关系(r=1.000),平均回收率为99.14%,RSD为0.63%(n=6);橙皮苷质量浓度在9.89~74.19μg/m L范围内与峰面积有良好线性关系(r=1.000),平均回收率为99.54%,RSD为0.31%(n=6)。结论该法灵敏、简便、准确,重现性好,线性关系良好,可作为制剂质量控制的标准。
Objective To establish an HPLC method for the content determination of giant knotweed polydatin, styrene glycosides ( TSG ) and hesperidin in Jiangzhi Granules. Methods Kromasil C18 ( 250 mm × 4. 6 mm, 5 μm ) column was used with acetonitrile-water ( 20 :80 ) as mobile phase;the detecting wavelength:283 nm and 320 nm. The column temperature was 30 ℃, the flow rate was 1. 0 mL /min. Results Polydatin, TSG and hesperidin in the concentration ranges of 5. 12-38. 40 μg/mL ( r=1. 000 ) , 1. 91~19. 09 μg/mL ( r=1. 000 ) , and 9. 89-74. 19 μg/mL ( r=1. 000 ) , respectively, exhibited a good linear relationship with the peak area. The average recovery rates of the above 3 compounds were 100. 13%, RSD=0. 63% ( n=6 );99. 14%, RSD=0. 63% ( n=6 );99. 54%, RSD=0. 31% ( n=6 ) . Conclusion This method is sensitive, simple and accurate with good reproducibility and fine linear relationship, and can be used for the quality control of said preparation.
出处
《中国药业》
CAS
2016年第13期74-76,共3页
China Pharmaceuticals
基金
江苏省医疗机构制剂标准提高科研专项课题
发文字号:苏食药监药注函〔2014〕64号