摘要
目的:建立穿琥宁原料药及其注射液的有关物质检查及含量测定方法。方法:采用高效液相色谱法,色谱柱为ODS柱(Shimpack CLC—ODS 150 mm×6.0 mm,5 μm),流动相为甲醇-水-磷酸(60:40:0.1),检测波长为251 nm。结果:能有效检查有关物质。有关物质检查的检测限为1.6 ng(S/N=3),线性范围约0.039-0.79μg(r=0.9978);含量测定方法的平均回收率为100.6%(n=9),线性范围0.48—2.40μg(r=0.9999)。结论:所建立的方法简便、灵敏、准确,可用于原料及其注射液的有关物质检查和含量测定。
Objectives: To determine Potassium Dehydroandrographolide Succinate (PDS) and the related substances in bulk drug and its aqueous solution for injection. Methods: RP-HPLC was adopted, the column was Shimpack CLC ODS(150 mm×6 mm,5μm) ,the mobile phase was methanol-water-phosphate(60: 40: 0.1) , the detection wavelength was 251 nm. Results: The calibration curve of assay was linear in the range of 0.48-2. 40μg(r=0. 9999) ,the average recovery was 100. 6% (n=9). In the related substances examination,the calibration curve was linear in the range of about 0.039-0.79μg(r=0.9978) ,the detective limit was 1. 6 ng (S/N=3). Conditions: This method is simple, sensitive and suitable for the assay and the related substances examination of PDS bulk drug and its aqueous solution for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第2期157-159,共3页
Chinese Journal of Pharmaceutical Analysis
