摘要
目的建立除湿注射液中龙胆苦苷和两种生物碱含量测定的HPLC方法并制定该制剂质量控制的指标。方法采用Diamondial C18反相柱,流动相为乙腈-水-三乙胺(9∶91∶0.5),用磷酸准确调节pH至6.75,流速1.0 mL·min^-1,检测波长215nm。结果苦参碱、槐果碱和龙胆苦苷在3.125-100μg·mL^-1范围内都呈良好的线性关系(r=0.999 9),回收率大于98%,日内、日间RSD均小于2%。结论本法操作简便,结果准确,重复性好,可用于除湿注射剂的质量控制。
OBJECTIVE To establish a HPLC method for the assay of gentiopicrin,matrine and sophocarpine in Chu Shi injection and formulate a standard for quality control.METHODS Diamonsil-C18 column was used as the stationary phase.Acetonitrile-water-triethylamine(9∶91∶0.5) was used as the mobile phase.Flow rate was 1 mL·min-1.The detection wavelength was set at 215 nm. RESULTS The linear ranges for matrine,sophocarpine and gentiopicrin were 3.125~100 μg·mL-1(r=0.999 9),the RSDs of within-day and between-day were less than 2.0%.CONCLUSION This HPLC method is simple,rapid,accurate and suitable for quality control of Chu Shi injection.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2007年第5期412-413,共2页
Chinese Journal of Modern Applied Pharmacy