Validated HPLC Method for Stability-Indicating Quantitative Determination of L-Carnitine in Pharmaceuticals and Supplements

Abstract

The study created a new stability-indicating reverse-phase high-pressure liquid chromatographic (RP-HPLC) method to measure the amount of L-carnitine in bulk and pharmaceutical dosage forms. Analytical performance parameters-system suitability (RSD = 0.14%; TP = 4696; TF = 1.36), assay (method precision = 99.68%; intermediate precision = 99.39%), accuracy (99.78%), specificity (both standard and sample are passed), stability (within ±2% of the standard), robustness, etc.-were determined according to ICH guidelines. The detection (LOD) and quantitation (LOQ) limits were 21 and 64 µg/ml, respectively. Percent recovery in the accuracy study was within the limit of 98 to 102%, which proved the method was validated for food supplements. However, the process was simple, precise, accurate, robust, and rapid, making it suitable for quantifying L-carnitine in pharmaceutical products and food supplements. The study created a new stability-indicating reverse-phase high-pressure liquid chromatographic (RP-HPLC) method to measure the amount of L-carnitine in bulk and pharmaceutical dosage forms. Analytical performance parameters-system suitability (RSD = 0.14%; TP = 4696; TF = 1.36), assay (method precision = 99.68%; intermediate precision = 99.39%), accuracy (99.78%), specificity (both standard and sample are passed), stability (within ±2% of the standard), robustness, etc.-were determined according to ICH guidelines. The detection (LOD) and quantitation (LOQ) limits were 21 and 64 µg/ml, respectively. The percent recovery in the accuracy study was within the limit of 98 to 102%, which proved the method was validated for food supplements. However, the process was simple, precise, accurate, robust, and rapid, making it suitable for quantifying L-carnitine in pharmaceutical products and food supplements.