HPLC测定阿娜尔妇洁液中苦参碱的含量

Content Determination of Matrine in A'naer Vigills by RP-HPLC

目的:以阿娜尔妇洁液为研究对象,建立阿娜尔妇洁液中苦参碱的含量测定方法。方法:采用RP-HPLC法,色谱柱Kromasil(4.6 mm×250 mm,5μm),流动相甲醇-0.04%三乙胺溶液(61∶39),流速0.7 mL.min-1,检测波长220 nm,柱温25℃,进样量10μL。结果:供试品中苦参碱在19.12～153.0 mg.L-1呈良好线性关系(r=0.999 8);平均回收率为95.17%,RSD 1.11%(n=9);供试品溶液在12 h内稳定。结论:本方法操作简便、可靠,灵敏度高、结果准确、重复性好,可用于阿娜尔妇洁液的质量控制,同时完善并提高了原有的药品质量标准。

Objective：To develop an RP-HPLC method for the determination of matrine content in A＇naer vigills.Method： By RP-HPLC,Kromasil（4.6 mm×250 mm,5 μm） column was used with mobile phase consisted of methanol-0.04% triethylamine（61∶39） and flow rate set at 0.7 mL·min-1.The detection wavelength was set at 220 nm and column temperature was set at 25 ℃.The injection volume was 10 μL.Result： The linear response range of matrine was 19.12-153.0 mg·L-1（r=0.999 8）.The average recovery was 95.17%,RSD was 1.11%（n=9）.The product in the 12 h solution in stability.Conclusion： The method is simple,reliable,sensitive,accurate and reproducible for quality control of A＇naer vigills.