摘要
目的建立高效液相色谱法测定雷公藤片及雷公藤多苷片中雷公藤红素的含量方法,并比较11个不同生产企业66批次雷公藤制剂中雷公藤红素含量。方法采用Welch UltimateTMXB-C18色谱柱,以乙腈-0.1%磷酸(80∶20)为流动相,柱温25℃,流速1mL.min-1,检测波长425nm。结果雷公藤红素在0.472~188.8μg.mL-1范围内与峰面积呈良好线性关系(r=0.9999),在雷公藤片及雷公藤多苷片中平均加样回收率(n=9)分别为98.32%(RSD=3.13%)和101.19%(RSD=2.17%)。结论该方法简单,准确,重复性好,可用于雷公藤制剂中雷公藤红素的含量测定。不同生产企业甚至同企业不同批次雷公藤制剂中雷公藤红素存在较大差异。
OBJECTIVE To develop an HPLC method for determination of tripterine in LGT tablets and LGTDG tablets.The contents of tripterine in tripterygii preparations were determined and compared among 66 batches of samples from 11 different manufactures.METHODS The determination was performed on Welch UltimateTM XBC18 column using acetonitrile-0.1% phosphoric acid(80 ∶ 20) as the mobile phase.The column temperature was 25℃,and the flow rate was 1mL·min^-1,as well as detection wavelength was 425nm.RESULTS The linear range of tripterine was 0.472 ~ 188.8μg·mL^-1,and the average recoveries were 98.32%(RSD =3.13%) and 101.19%(RSD =2.17%) in LGT tablets and LGTDG tablets respectively.CONCLUSION The method is simple,accurate and reproducible.It can be applied to determine the contents of tripterine in LGT tablets and LGTDG tablets.The contents of tripterine in tripterygii preparations are varied significantly from different manufactures or even from different batches of the same manufacture.
出处
《海峡药学》
2013年第6期29-31,共3页
Strait Pharmaceutical Journal