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.
Formulation and Process Development, Gilead Sciences, Inc., Foster City, CA 94404, USA. gong-xin_he@gilead.com
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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