HPLC determination of L-carnitine injection and its related substances.docVIP

 PAGE \* MERGEFORMAT 12 HPLC determination of L-carnitine injection and its related substances Of: Min Cui E, Lu Yuan, Jiang little device, Tan won with [Abstract] Objective To determine the content of L-carnitine injection and related substances. Methods using high performance liquid chromatography, column: MC Pack NH2 column (4.6 mm 150 mm, 5 m); mobile phase: 0.05 mol L-1 phosphate buffer-acetonitrile (35:65 volume ratio), phosphoric acid pH adjusted to 4.3; detection wavelength: 205 nm; flow rate: 1 mL min-1; column temperature: 30 . the results of L-carnitine in 1.04 ~ 8.30 mg mL-1 concentration and peak area within the linear relationship, r = 0.999 9; high, medium and low concentrations of 3, the average recovery was 100.7%, RSD was 1.4%. Left carnitine detection limit of 3 ng, related materials (E) 4 (c-methyl-amino) ester or 2-butene (Z) 4 (c-methyl-amino) ester 2-butene the detection limit was 0.02 ng. Conclusion The method is simple , accurate, sensitive, reproducible, L-carnitine injection for quality control. [Key Words] high performance liquid chromatography; L-carnitine; injection; related substances; quality control Abstract: Objective To establish a HPLC method for the determination of levocarnitine Injection and its related substances.Method The HPLC was carried out on a YMC Pack NH2 (150 mm 4.6 mm, 5m) column with a flow rate of 1.0 mL min- 1 at column temperature 30 , of which the mobile phase was consisted of 0.05 mol L-1 solution of phosphate buffer and acetonitrile (35:65, pH4.3) and the detected UV wavelength was 205 nm. Results The calibration curve was linear (r = 0.999 9) in the range of 1.04 ~ 8.30 mg mL-1 for levocarnitine, and the average recovery was 100.7%, with RSD 1.4%. The limit of detection was 3 ng for levocarnitine and 0.02 ng for its impurity A. Conclusion It is an accurate, simple, rapid, qualitative method with good reproducibility for the determination of levocarnitine and its related substances.