HPLC测定复方氨酚烷胺颗粒中人工牛黄的含量

Determination of Calculus Bovis Artifactus in Compound Paracetamol and Amantadine Hydrochloride Granules by HPLC

关键词:  复方氨酚烷胺颗粒  人工牛黄  高相液相色谱法

Key words:  compound paracetamol and amantadine hydrochloride granules  calculus bovis artifactus  HPLC

摘要:

目的建立复方氨酚烷胺颗粒中人工牛黄含量测定的高相液相色谱法。方法 采用HPLC对人工牛黄中胆红素进行定量测定，采用SHIMADZU C18色谱柱(4.6 mm×250 mm，5 μm)，流动相为甲醇-氯仿-1%磷酸溶液(80∶14∶6)，检测波长为449 nm，流速为1.0 mL·min-1。结果 胆红素在2.50～17.5 μg·mL-1内呈良好的线性关系(r =0.999 7)，平均回收率为100.4%，RSD为1.3%(n=9)，重复性试验RSD为0.15%(n=9)。结论所建立的方法可准确、快速地进行定量检测，可用于该制剂的质量控制。

Abstract:

OBJECTIVE To establish an HPLC method for calculus bovis artifactus of compound paracetamol and amantadine hydrochloride granules. METHODS To establish a determination method of bilirubin in calculus bovis artifactus by HPLC, SHIMADZU-C18 column(4.6 mm × 250 mm，5 μm) was used, the mobile phase consisted of methanol-chloroform-1% phosphoric acid solution (80∶14∶6), the detection wavelength was 449 nm and the flow rate was l.0 mL·min-1. RESULTS Bilirubin showed a good linear relationship at the range of 2.50-17.5 μg·mL-1(r=0.999 7). The average recovery of assay was l.6%(n=9). CONCLUSION This mehod is accurate and fast, and can be used for the quality control of these granules．