摘要
目的：建立RP-HPLC法测定吲哚美辛巴布膏的含量和有关物质。方法：采用Agilent ZORBAX Eclipse Plus C18色谱柱（4.6 mm×150 mm,5μm）,以甲醇-水-磷酸（600∶400∶1）为流动相,流速1.0 mL·min^-1,检测波长228 nm,柱温40℃。结果：吲哚美辛浓度在0.5～10μg·mL-1及10～200μg·mL-1范围内呈良好线性关系（r=0.9999）;方法的平均回收率（n=9）为99.3%,RSD=1.1%;3批样品含量测定结果分别为98.4%、97.1%和98.2%,有关物质检查中吲哚美辛峰与各杂质分离度符合要求。结论：经方法学验证,该方法可用于控制吲哚美辛巴布膏主药及有关物质的含量测定。
Objective： To establish an RP- HPLC method for determination of Indometacin Patch and its related substances. Methods： The column was Agilent ZORBAX Eclipse Plus C18（ 4. 6 mm ×150 mm,5 μm）. The mobile phase was composed of methanol- water- phosphoric acid（ 600∶ 400∶ 1） at a flow rate of 1. 0 mL·min- 1. The detection wavelength was 228 nm and the column temperature was 40 %C. Results： The calibration curves were linear in the ranges of 0. 50- 100 μg·mL- 1and 10. 0- 200. 0 μg·mL- 1. The average recovery（ n = 9） was 99. 3%with a RSD of 1. 1%. The content determination results for the 3 batches of samples were 98. 4%,97. 1% and98. 2%,respectively. The resolution between indometacin and its related substances was acceptable. Conclusion：The method is suitable for determination of the content and related substances of indometacin patch according to the methodological verification.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2014年第7期1310-1314,共5页
Chinese Journal of Pharmaceutical Analysis
