高效液相色谱法测定新肾炎胶囊中蒽醌类化合物的含量

Determination of Anthraquinones in Xinshenyan Capsules by HPLC

目的建立高效液相色谱法（HPLC）测定新肾炎胶囊中蒽醌类化合物大黄酸、大黄素、大黄酚的含量。方法采用Phenomenex C18柱（4.6 mm×250 mm,5μm）,以甲醇-1%醋酸（70∶30）为流动相,检测波长254 nm,柱温25℃;流速1 m L·min-1。结果大黄酸、大黄素、大黄酚检测浓度分别在4.96~24.80μg·m L-1（r=0.999 6）、6.58~32.91μg·m L-1（r=0.999 9）、15.11~75.55μg·m L-1（r=0.999 9）范围内与峰面积呈良好的线性关系,平均加样回收率分别为100.78%,98.13%,99.29%。结论制剂制备工艺稳定,建立的含量测定方法简便、可靠,可用于制定主要治疗成分大黄素、大黄酚的含量下限以及非主要治疗成分大黄酸的含量上限,进一步保障制剂安全。

Objective To establish an HPLC method for the determination of anthraquinones including rhein, emodin and chrysophanal in xinshenyan capsules. Methods Anthraquinones were determined by HPLC with Phenomenex-C18 column （250 mm×4.6 mm, 5 μm） as the chromatographic column and methanol-1% acetic acid （70 ： 30） as the mobile phase. The flow rate was 1.0 mL· min-1 and the detection wavelength was set at 254 rim. Results The liner range of rhein, emodin and chrysophanol was 4.96-24.80μg· mL-1（r=0. 999 6）, 6.58-32.91 μg · mL-1（r=0. 999 9） , and 15.11-75.55 μg · mL-1 （r=0.999 9） ,respectively, and the average recovery was 100.78%, 98.13% and 99.29% , respectively. Conclusion The method is simple and practical, the result is accurate and reliable and it can be used to determine the contents of rhein, emodin and chrysophanol in xinshenyan capsules.