摘要
目的:建立反相高效液相色谱法测定穿琥宁氯化钠注射液中穿琥宁含量及有关物质的方法。方法:采用RP-HPLC法,使用Shim-pack CLC-ODS柱(6.0 mm × 150 mm,5μm),以0.01 mol·L-1磷酸二氢钾溶液(用磷酸调pH至2.5)-甲醇-四氢呋喃(9:6:4)为流动相,流速为1.0 mL·min-1,在251 nm波长处,测定穿琥宁氯化钠注射液中穿琥宁含量及有关物质。结果:该方法的线性范围为0.02～0.20μg(r=0.9993)、0.50～10.0μg(r=0.9992);平均回收率为99.35%,RSD=0.79%(n=9)。结论:该方法测定样品分离效果佳,灵敏度高,重现性好,结果准确可靠。
Objective: To establish HP - HPLC method for determination of the content of potassium dehydroan-drographolide succinate in potassium dehydroandrographolide succinate and sodium chloride injection and its related substances. Methods: An optimal RP - HPLC method was set up. The samples were separated by Shim - pack CLC - ODS column(6. 0 mm×150 mm,5μm) with 0. 01 mol· L-1 monopotassium phosphate(adjust pH to 2. 5 using phosphoric acid) - methanol - tetrahydrofuran(9: 6: 4) as mobile phase and detected with UV 251 nm and a flow rate of 1. 0 mL· min-1. Results:The calibration curve was linear in the range of 0. 02 -0. 20μg(r =0. 9993)for determination of its related substances,0. 50 - 10. 0 μg(r =0. 9992) for the content determination;The average recovery rate was 99. 35% ,RSD =0. 79% (n =9). Conclusion:The method is good in the aspect of separable effect, reproducibility and sensitivity.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2004年第1期27-30,共4页
Chinese Journal of Pharmaceutical Analysis
基金
四川省重点科技项目:中药制剂现代化研究(批准号:01SG008-01)
关键词
RP—HPLC法
测定
穿琥宁氯化钠注射液
穿琥宁
含量
potassium dehydroandrographolide succinate and sodium chloride injection, potassium dehydroan-drographolide succinate, RP - HPLC, related substances
