HPLC法测定哮喘片中麻黄碱的含量

HPLC method for determining the content of ephedrine in asthma tablets

目的优化HPLC法测定哮喘片中麻黄碱含量的色谱条件。方法采用HPLC法测定含量。采用Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-0.5%三乙胺(2∶98)(磷酸调节p H值至2.5)为流动相,流速为1.0 m L·min-1,柱温为30℃,检测波长为210 nm,以外标法测定。结果哮喘片中主要活性成分麻黄碱与其他组分之间基线分离良好。麻黄碱的进样量在0.051 18~0.451 44μg内与其峰面积之间有良好的线性关系(r=0.999 9),平均加样回收率为99.98%,RSD=0.7%。结论该方法线性好,稳定性、重复性高,结果准确可靠,可作为哮喘片的质量控制检测方法。

AIM To optimize the chromatographic conditions for using the HPLC method to measure the ephedrine content in asthma tablets. METHODS The HPLC method was used to measure the content. Chromatographic conditions： a Diamonsil C18 chromatographic column （250 mm × 4.6 mm, 5 μm） , with the methanol- 0.5% triethylamine （2： 98） （the pH value adjusted with the phosphoric acid to 2.5） as the mobile phase, and with the flow rate of 1.0 mL·min^-1, the column temperature of 30℃ and the test wavelength of 210 nm. The content was measured with the external standard method. RESULTS The ephedrine, as the main active component in asthma tablets, had good baseline separation with other components. The peak area and sampling size of the ephedrine had good linear relationship in the range of 0. 051 18 -0. 451 44 μg （r =0. 999 9）. The av- erage sample recovery rate was 99.98% and RSD = 0.7%. CONCLUSION The method has the advantages of good linearity, stability, reproducibility and recovery rate, and the result is accurate and reliable, and therefore can be used as a quality control detection method for asthma tablets.