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...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.展开更多
文摘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.
