Quantitative Determination of L-Carnitine Tablet Formulation by A Validated Stability-Indicating Reversed-Phase HPLC Method

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جامعة الشيخ عبدالله البدري
Abstract: A rapid and stability-indicating RP-HPLC method was developed for determination of L-Carnitine in tablets dosage form. The method was developed on C18 column (250 x 4.6 mm ID) using the mobile phase composition as 0.05M phosphate buffer (pH = 3.2) Methanol: buffer (5:95 V/V). The flow rate was set as 0.9ml/minute and the maximum absorption was observed at 225 nm. The method was validated for specificity, selectivity, linearity, precision, accuracy, and robustness. The L-Carnitine drug showed a precise and good linearity at the concentration ranges of 70- 1120 µg/ml. The RP-HPLC, assay showed the highest purity ranging 99.74% to 99.84 % for L-Carnitine tablet formulation and 99.80 % was the mean percentage purity. The L-Carnitine retention time was found to be 7.7 minutes. The method accuracy was showed by statistical analysis. The developed RP-HPLC method can be adopted for the routine analysis of L-Carnitine pharmaceutical dosage forms in quality control laboratories. The developed method was validated according to the ICH guidelines. Accordingly, the proposed validated and rapid procedure was proved to be suitable for routine analyzing and stability studies of L-Carnitine in tablets.