中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2014年
3期
199-202
,共4页
汪玉馨%刘琦%史清水%陆益红
汪玉馨%劉琦%史清水%陸益紅
왕옥형%류기%사청수%륙익홍
门冬氨酸钾镁%离子色谱法%含量测定
門鼕氨痠鉀鎂%離子色譜法%含量測定
문동안산갑미%리자색보법%함량측정
potassium aspartate and magnesium aspartate%ion chromatography%assay
目的:建立测定注射用门冬氨酸钾镁中无水门冬氨酸钾镁含量的方法。方法:采用离子色谱法,色谱柱为CS12A(4 mm ×250 mm),保护柱为CG12A(4 mm ×50 mm);电导检测器,阳离子抑制器;流动相为25 mmol· L-1甲烷磺酸溶液,流量为1 mL· min-1;柱温30℃。结果:无水门冬氨酸钾在22.08~441.64μg· mL-1范围内,色谱峰面积与其浓度成良好线性关系(Y=0.0377X-0.0145,R2=1),回收率为100.1%,RSD为0.7%;无水门冬氨酸镁在24.09~481.84μg· mL-1范围内,色谱峰面积与其浓度成良好线性关系(Y=0.0409X-0.0088,R2=1),回收率为100.9%,RSD为0.4%。结论:本方法可简便、快速、准确地对注射用门冬氨酸钾镁中无水门冬氨酸钾镁含量进行测定。
目的:建立測定註射用門鼕氨痠鉀鎂中無水門鼕氨痠鉀鎂含量的方法。方法:採用離子色譜法,色譜柱為CS12A(4 mm ×250 mm),保護柱為CG12A(4 mm ×50 mm);電導檢測器,暘離子抑製器;流動相為25 mmol· L-1甲烷磺痠溶液,流量為1 mL· min-1;柱溫30℃。結果:無水門鼕氨痠鉀在22.08~441.64μg· mL-1範圍內,色譜峰麵積與其濃度成良好線性關繫(Y=0.0377X-0.0145,R2=1),迴收率為100.1%,RSD為0.7%;無水門鼕氨痠鎂在24.09~481.84μg· mL-1範圍內,色譜峰麵積與其濃度成良好線性關繫(Y=0.0409X-0.0088,R2=1),迴收率為100.9%,RSD為0.4%。結論:本方法可簡便、快速、準確地對註射用門鼕氨痠鉀鎂中無水門鼕氨痠鉀鎂含量進行測定。
목적:건립측정주사용문동안산갑미중무수문동안산갑미함량적방법。방법:채용리자색보법,색보주위CS12A(4 mm ×250 mm),보호주위CG12A(4 mm ×50 mm);전도검측기,양리자억제기;류동상위25 mmol· L-1갑완광산용액,류량위1 mL· min-1;주온30℃。결과:무수문동안산갑재22.08~441.64μg· mL-1범위내,색보봉면적여기농도성량호선성관계(Y=0.0377X-0.0145,R2=1),회수솔위100.1%,RSD위0.7%;무수문동안산미재24.09~481.84μg· mL-1범위내,색보봉면적여기농도성량호선성관계(Y=0.0409X-0.0088,R2=1),회수솔위100.9%,RSD위0.4%。결론:본방법가간편、쾌속、준학지대주사용문동안산갑미중무수문동안산갑미함량진행측정。
Objective:To establish an assay method of potassium aspartate and magnesium aspartate in potassium aspartate and magnesi -um aspartate for injection by ion chromatography (IC).Methods:The assay was performed on CS12A column(4 mm ×250 mm)and CG12A guard column (4 mm ×50 mm) with cationic suppressor and electrolytic conductivity detector.The mobile phase was 25 mmol · L-1 methanesulfonic acid solution with 1 mL· min-1 flow rate.The temperature of column was 30 ℃.Results: Within 22.08-441.64 μg· mL-1 potassium aspartate had a good linearity (Y=0.0377X-0.0145,R2 =1),the average recovery was 100.1% with RSD of 0.7%.Within 24.09-481.84 μg· mL-1 magnesium aspartate had a good linearity (Y=0.0409X-0.0088,R2 =1),the av-erage recovery was 100.9%with RSD of 0.4%.Conclusion:The method is proved to be simple ,rapid and sensitive for evaluating the quality of potassium aspartate and magnesium aspartate in potassium aspartate and magnesium aspartate for injection .