Improved high-performance liquid chromatographic method for analysis of L-carnitine in pharmaceutical formulations.
A reversed-phase high performance liquid chromatographic method for analysis of L-carnitine is described. The improved method is able to provide a high resolution between L-carnitine and crotonoylbetaine, a major impurity and degradation product, and suitable for quantitative analysis of L-carnitine in pharmaceutical formulations, such as solution, tablets, and capsules. The resolution, linearity, accuracy and reproducibility of the method are discussed.
He
G X
GX
Formulation and Process Development, Gilead Sciences, Inc., Foster City, CA 94404, USA. gong-xin_he@gilead.com
Dahl
T
T
D002138:Calibration; D002331:Carnitine / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D004364:Pharmaceutical Preparations; D002331:Carnitine