HPLC法测定左卡尼汀注射液中的有关物质

HPLC Determination of Related Substances in Levocarnitine Injection

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