摘要
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AlltimaAmino色谱柱(4.6mm×250mm,5μm),流动相为乙腈m.05mol·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205nm;柱温为30℃;流量为0.7mL·min-1。结果:左卡尼汀杂质A在0.001—0.500mg·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。
Objective: To develop an HPLC method for the determination of related substances in Levocarnitine Injection. Method: The assay was performed on an A11tima Amino column (4. 6 mm × 250 mm,5 μm) with 0. 05 mol · L-1 potassium dihydrogen phosphate 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. Key words: Levocarnitine Injection ; HPLC ; related substance
出处
《中国药品标准》
CAS
2015年第4期263-267,共5页
Drug Standards of China