中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
4期
263-267
,共5页
郭丽娟%于黎鑫%王爱凤%崔美兰
郭麗娟%于黎鑫%王愛鳳%崔美蘭
곽려연%우려흠%왕애봉%최미란
左卡尼汀注射液%高效液相色谱法%有关物质
左卡尼汀註射液%高效液相色譜法%有關物質
좌잡니정주사액%고효액상색보법%유관물질
Levocarnitine Injection%HPLC%related substance
目的::建立HPLC法测定左卡尼汀注射液中有关物质的方法。方法:采用Alltima Amino色谱柱(4.6 mm ×250 mm,5μm),流动相为乙腈-0.05 mol·L-1磷酸二氢钾溶液(用磷酸调节pH值至4.3)(65∶35);检测波长为205 nm;柱温为30℃;流量为0.7 mL·min-1。结果:左卡尼汀杂质A在0.001~0.500 mg·mL-1范围内线性关系良好(r=0.9998),平均回收率为100.08%,RSD为1.14%(n=9)。结论:建立的方法灵敏度高,测定结果准确,可用于左卡尼汀注射液中有关物质的测定。
目的::建立HPLC法測定左卡尼汀註射液中有關物質的方法。方法:採用Alltima Amino色譜柱(4.6 mm ×250 mm,5μm),流動相為乙腈-0.05 mol·L-1燐痠二氫鉀溶液(用燐痠調節pH值至4.3)(65∶35);檢測波長為205 nm;柱溫為30℃;流量為0.7 mL·min-1。結果:左卡尼汀雜質A在0.001~0.500 mg·mL-1範圍內線性關繫良好(r=0.9998),平均迴收率為100.08%,RSD為1.14%(n=9)。結論:建立的方法靈敏度高,測定結果準確,可用于左卡尼汀註射液中有關物質的測定。
목적::건립HPLC법측정좌잡니정주사액중유관물질적방법。방법:채용Alltima Amino색보주(4.6 mm ×250 mm,5μm),류동상위을정-0.05 mol·L-1린산이경갑용액(용린산조절pH치지4.3)(65∶35);검측파장위205 nm;주온위30℃;류량위0.7 mL·min-1。결과:좌잡니정잡질A재0.001~0.500 mg·mL-1범위내선성관계량호(r=0.9998),평균회수솔위100.08%,RSD위1.14%(n=9)。결론:건립적방법령민도고,측정결과준학,가용우좌잡니정주사액중유관물질적측정。
Objective:To develop an HPLC method for the determination of related substances in Levocarnitine Injection. Method: <br> The assay was performed on an Alltima Amino column (4. 6 mm × 250 mm,5 μm) with 0. 05 mol·L-1 potassium dihydrogen phos-phate solution(adjusted pH to 4. 3 with phosphoric acid)-acetonitrile(65∶35) as mobile phase at a flow rate of 0. 7 mL·min-1;The column temperature was 30 ℃ and detected with UV 205 nm. Results:A good linearity was obtained in 0. 001-0. 500 mg·mL-1 for Levocarnitine impurity A (r=0. 999 8), the average recovery was 100. 08% and RSD was 1. 14% (n=9). Conclusion:The method can be used for the assay of related substances in Levocarnitine Injection with high sensitivity, accurate and reliable results.