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has been cited by the following article:

• TITLE: Analytical Method Development and Validation of Content of D-Carnitine in Levocarnitine Using High-Performance Liquid Chromatography

  AUTHORS: M. Narasimha Naidu, Kannan Jakkan, P. Sanjeeva, P. Venkata Ramana

  KEYWORDS: Carnitine, D-Carnitine, Levocarnitine, HPLC

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.15 No.12, December 31, 2024

  ABSTRACT: A novel HPLC method was developed and validated for the determination of D-Carnitine in Levocarnitine in accordance with the ICH Q2R1 guidelines. The method demonstrated system precision, specificity, precision at the limit of quantitation (LOQ), accuracy, solution stability, linearity, ruggedness and robustness. The HPLC conditions consisted of a mobile phase composed of pH 2.60 buffer, acetonitrile, and tetrahydrofuran (THF) in a ratio of 850:90:60 (v/v/v), with a flow rate of 1.0 mL/min and UV detection at 244 nm. The entire chromatography run time was set to 65 minutes. Linearity was established over a concentration range of LOQ-160% with a correlation coefficient of 0.996. Accuracy was confirmed within the range between LOQ and 160%. This validated HPLC method is suitable for the precise quantification of D-Carnitine in Levocarnitine Tablets, making it an effective tool for quality control and assurance in pharmaceutical manufacturing.