首都食品与医药
首都食品與醫藥
수도식품여의약
Capital Medicine
2015年
18期
70-71
,共2页
感愈胶囊%盐酸金刚烷胺%对乙酰氨基酚%HPLC-ELSD法%含量测定
感愈膠囊%鹽痠金剛烷胺%對乙酰氨基酚%HPLC-ELSD法%含量測定
감유효낭%염산금강완알%대을선안기분%HPLC-ELSD법%함량측정
Ganyu Capsules%Amantadine Hydrochloride%Paracetamol%HPLC-ELSD%Determination
目的：建立HPLC-ELSD法测定感愈胶囊中盐酸金刚烷胺及对乙酰氨基酚的含量的方法。方法采用CAPCELL PAK MGⅡC18(4.6mm×150mm，5μm)色谱柱，流动相为乙腈-0.06%三氟乙酸溶液（20∶80），流速0.6mL?min-1，柱温30℃，进样量10μL，ELSD检测器漂移温度为100℃，雾化气体为空气，气流速度为2.0L?min-1。结果盐酸金刚烷胺和对乙酰氨基酚分别在2.1184～12.7104μg、4.9736～29.8416μg范围内进样量与峰面积的对数具有良好线性关系（r=0.9999，0.9999）；二者平均回收率分别为99.55%和100.07%，RSD分别为1.24%，0.97%（n=6）。结论本法简便、准确、分离效果好，可用于感愈胶囊的质量控制。
目的：建立HPLC-ELSD法測定感愈膠囊中鹽痠金剛烷胺及對乙酰氨基酚的含量的方法。方法採用CAPCELL PAK MGⅡC18(4.6mm×150mm，5μm)色譜柱，流動相為乙腈-0.06%三氟乙痠溶液（20∶80），流速0.6mL?min-1，柱溫30℃，進樣量10μL，ELSD檢測器漂移溫度為100℃，霧化氣體為空氣，氣流速度為2.0L?min-1。結果鹽痠金剛烷胺和對乙酰氨基酚分彆在2.1184～12.7104μg、4.9736～29.8416μg範圍內進樣量與峰麵積的對數具有良好線性關繫（r=0.9999，0.9999）；二者平均迴收率分彆為99.55%和100.07%，RSD分彆為1.24%，0.97%（n=6）。結論本法簡便、準確、分離效果好，可用于感愈膠囊的質量控製。
목적：건립HPLC-ELSD법측정감유효낭중염산금강완알급대을선안기분적함량적방법。방법채용CAPCELL PAK MGⅡC18(4.6mm×150mm，5μm)색보주，류동상위을정-0.06%삼불을산용액（20∶80），류속0.6mL?min-1，주온30℃，진양량10μL，ELSD검측기표이온도위100℃，무화기체위공기，기류속도위2.0L?min-1。결과염산금강완알화대을선안기분분별재2.1184～12.7104μg、4.9736～29.8416μg범위내진양량여봉면적적대수구유량호선성관계（r=0.9999，0.9999）；이자평균회수솔분별위99.55%화100.07%，RSD분별위1.24%，0.97%（n=6）。결론본법간편、준학、분리효과호，가용우감유효낭적질량공제。
Objective To develop a method for determining the contents of Amantadine Hydrochloride and Paracetamol in Ganyu Capsules by HPLC-ELSD.Methods The column was CAPCELL PAK MGⅡC18 (4.6mm×150mm,5μm),the mobile phase was acetonitriles -0.06% trifluoroacetic acid solution(20∶80 )at the flow rate of 0.6mL?min-1,the column temperature was 30℃ and the injection volume was 10μL; ELSD was used as detector, the drift tube temperature was 100℃ and nebulizer gas was air and the flow rate was 2.0L?min-1.Results The logarithm of the contents of Amantadine Hydrochloride had good linear relation-ship with the logarithm of their peak area in the scope of 2.1184~12.7104μg(r=0.9999),and the logarithm of the contents of Parac-etamol had good linear relationship with the logarithm of their peak area in the scope of 4.9736~29.8416μg(r=0.9999).The average recoveries were 99.55% and 100.07%. (RSD=1.27%,0.97%)(n=6).Conclusion The method is simple, accurate and well-separated, and it is applicable for the quality control of Ganyu Capsules.
