西南国防医药
西南國防醫藥
서남국방의약
MEDICAL JOURNAL OF NATIONAL DEFENDING FORCES IN SOUTHWEST CHINA
2014年
10期
1055-1057
,共3页
芬戈莫德%含量%测定%高效液相色谱法
芬戈莫德%含量%測定%高效液相色譜法
분과막덕%함량%측정%고효액상색보법
fingolimod%contents%determination%HPLC
目的：建立 HPLC 芬戈莫德胶囊含量测定方法。方法采用高效液相色谱法测定芬戈莫德胶囊中芬戈莫德的含量。选用色谱柱为 Agilent TC-C18，流动相为高氯酸钠溶液（0.1 mol/ L 高氯酸钠水溶液，高氯酸调节 pH 值为2.8）：甲醇：乙腈（93：7：100）；检测波长215 nm，流速1.5 ml/ min；进样量10μl。结果芬戈莫德浓度线性范围为0.0499~0.1499 mg/ ml （r =0.9998）；样品平均回收率为100.01%（RSD =0.46%，n =3）。结论本法操作简便，重现性好，准确性高，可用于芬戈莫德胶囊的含量测定质量控制。
目的：建立 HPLC 芬戈莫德膠囊含量測定方法。方法採用高效液相色譜法測定芬戈莫德膠囊中芬戈莫德的含量。選用色譜柱為 Agilent TC-C18，流動相為高氯痠鈉溶液（0.1 mol/ L 高氯痠鈉水溶液，高氯痠調節 pH 值為2.8）：甲醇：乙腈（93：7：100）；檢測波長215 nm，流速1.5 ml/ min；進樣量10μl。結果芬戈莫德濃度線性範圍為0.0499~0.1499 mg/ ml （r =0.9998）；樣品平均迴收率為100.01%（RSD =0.46%，n =3）。結論本法操作簡便，重現性好，準確性高，可用于芬戈莫德膠囊的含量測定質量控製。
목적：건립 HPLC 분과막덕효낭함량측정방법。방법채용고효액상색보법측정분과막덕효낭중분과막덕적함량。선용색보주위 Agilent TC-C18，류동상위고록산납용액（0.1 mol/ L 고록산납수용액，고록산조절 pH 치위2.8）：갑순：을정（93：7：100）；검측파장215 nm，류속1.5 ml/ min；진양량10μl。결과분과막덕농도선성범위위0.0499~0.1499 mg/ ml （r =0.9998）；양품평균회수솔위100.01%（RSD =0.46%，n =3）。결론본법조작간편，중현성호，준학성고，가용우분과막덕효낭적함량측정질량공제。
Objective To establish a method for determining the contents of fingolimod in fingolimod capsules by High Performance Liquid Chromatography( HPLC). Methods HPLC was used to determine the contents of fingolimod in fingolimod capsules. The selected column was Agilent TC-C18,and the mobile phase was sodium perchlorate solution(0. 1 mol/ L aqueous solution of sodium perchlorate,and the pH value of perchloric acid had been adjusted to 2. 8):methanol :acetonitrile(93:7:100);the detection wavelength was 215 nm with a flow rate of 1. 5 ml/ min;the sample size is 10 μl. Results The linear range of concentration of fingolimod was 0. 0499 ~ 0. 1499 mg/ ml(r = 0. 9998);the average recovery rate of samples was 100. 01%(RSD = 0. 46% ,n = 3). Conclusion This method is simple with high reproducibility and high accuracy,and can be used to determine the contents of fingolimod in fingolimod capsules for quality control.
