摘要
本试验旨在建立射干地龙颗粒中次野鸢尾黄素的含量测定方法及考察该制剂的稳定性,为制定该制剂质量标准中含量测定方法及保质期提供依据。采用反相高效液相色谱(RP-HPLC)法,色谱柱:GL Sciences Inertsil ODS-3(150mm×4.6mm,5μm),流动相:乙腈-0.2%磷酸溶液(39∶61),流速:1mL/min,检测波长:266nm,柱温:30℃,进样量:10μL;根据药典,采用强光照射试验、加速试验及长期稳定性试验考察射干地龙颗粒中次野鸢尾黄素含量的稳定性。试验结果表明,次野鸢尾黄素的含量在0.3422～86.60μg/mL范围内与峰面积呈良好的线性关系,r=0.9995(n=10),平均加样回收率为99.80%,RSD为1.50%(n=9);强光照射试验、加速试验及长期稳定性试验结果表明,该产品稳定性良好;此方法简便、灵敏、重现性好,可用于射干地龙颗粒中次野鸢尾黄素的含量测定,且该制剂的稳定性良好。
The study was aimed to establish a method for determining Irisflorentin in Shegan Dilong granules and inspection for the stability of the preparation. RP-HPLC method was adopted and the GL Sciences Inertsil ODS-3 （150 mm×4.6 mm, 5 μm） was used. The mobile phase was acetonitrile-0.2% phosphoric acid solution （39～61）, with the flow rate of 1 mL/min. The detection wavelength was at 266 nm and the column temperature was 30 ℃. Under the high-light exposure experiment,ac- celerating experiment and room temperature storage observation, the results showed that the product was basically stable. The calibration curve of Irisflorentin was linear in the range of 0. 3422 to 86.60 μg/mL, r was 0. 9995 （n was 10）, the average re- covery rate was 99.80%, RSD was 1.50% （n was 9）. The method was simple, sensitive and accurate with good repeatability, which could be used for the quality control of Shegan Dilong granules and the preparation had a good stability.
出处
《中国畜牧兽医》
CAS
北大核心
2013年第7期29-33,共5页
China Animal Husbandry & Veterinary Medicine
基金
“十二五”国家科技支撑计划项目资助(2011BAD34B03)
中央级公益性科研院所基本科研业务费专项资金项目(1610322013015)
