摘要
目的： 建立反相高效液相色谱法测定穿琥宁及其注射液的含量。方法： 采用μＢｏｎｄｐａｋ Ｃ１８ 色谱柱， 甲醇－水（７０∶３０） 为流动相，２５０ ｎｍ 为检测波长， 室温下对穿琥宁及其注射剂进行含量测定。结果： 能将穿琥宁及其主要杂质穿心莲内酯进行分离； 穿琥宁在２５ ～４００ μｇ·ｍＬ－ １ 范围内， 峰面积与其浓度线性关系良好（ｒ＝ ０－９９９ ９） ； 样品平均回收率为１００－６ ％ ； 日内精密度ＲＳＤ 为１－０８％ （ｎ ＝ ５）， 日间（１０ ｄ 内） 精密度ＲＳＤ为２－０６ ％ （ｎ＝ ５） 。结论： 该法简便、快速、专属性强， 可以满足其原料和制剂的质量控制要求。
Objective:To establish a method using RP-HPLC for determination of the content of potassium dehydroandrographolide succinate and its injections.Method:The instrument was LC-3A HPLC with a μBondapak C 18 column (25 cm×4 6 mm,10 μm),the mobile phase was methanol-water(70∶30) and the flow rate was 1 0 mL·min -1 . The UV detection wavelength was 250 nm and column temperature was room temperature.Results:It can separate the potassium dehydroandrographolide succinate and its primary impurity andrographolide. The calibration curve was linear( r =0 999 9)within the range of 25～400 μg·mL -1 for potassium dehydroandrographolide succinate, the mean recovery was 100 6%, the within-day precision RSD was 1 08%( n =5) and day-to-day precision RSD was 2 06% ( n =5) at three drug levels. Conclusion:This method is simple, quick and specific, suitable for the quality control of the drug and its preparation.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2000年第1期29-31,共3页
Chinese Journal of Pharmaceutical Analysis
关键词
穿琥宁
穿心莲内酯
高效液相色谱
potassium dehydroandrographolide succinate, andrographolide, RP-HPLC
