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. 2014 Oct 22:2014:481059.
doi: 10.1155/2014/481059. eCollection 2014.

Validation of a Stability-Indicating RP-HPLC Method for Determination of l-Carnitine in Tablets

Roghaieh Khoshkam  1 , Minoo Afshar  1
Affiliations

Validation of a Stability-Indicating RP-HPLC Method for Determination of l-Carnitine in Tablets

Roghaieh Khoshkam et al. Int Sch Res Notices. .

Abstract

A rapid and stability-indicating RP-HPLC method was developed for determination of l-carnitine in tablets. The separation was based on a C18 analytical column using a mobile phase which consisted of 0.05 M phosphate buffer (pH = 3): ethanol (99 : 1), including 0.56 mg/mL of sodium 1-heptanesulfonate. Column temperature was set at 50°C and quantitation was achieved by UV detection at 225 nm. In forced degradation studies, the drug was subjected to oxidation, hydrolysis, photolysis, and heat. Among the different stress conditions, the exposure to acidic and basic conditions was found to be an important adverse stability factor. The method was validated for specificity, selectivity, linearity, precision, accuracy, and robustness. The applied procedure was found to be linear in l-carnitine concentration range of 84.74-3389.50 µg/mL (r (2) = 0.9997). Precision was evaluated by replicate analysis in which relative standard deviation (RSD) values for areas were found below 2.0%. The recoveries obtained (100.83%-101.54%) ensured the accuracy of the developed method. The expanded uncertainty (3.14%) of the method was also estimated from method validation data. Accordingly, the proposed validated and rapid procedure was proved to be suitable for routine analyzing and stability studies of l-carnitine in tablets.

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Figures

Figure 1
Figure 1
Molecular structures of l-carnitine (a) and crotonoylbetaine (b).
Figure 2
Figure 2
Typical chromatogram of l-carnitine and its main impurity (crotonoylbetaine).
Figure 3
Figure 3
Typical chromatograms of l-carnitine after degradation under (a) photolytic condition; (b) oxidative condition: peak 4 = hydrogen peroxide; (c) basic hydrolysis; peak 3 = unknown impurity (d); acidic hydrolysis: peak 3 = unknown impurity, peak 2 = Impurity A; (e) heat condition; and (f) l-carnitine working standard solution (1355.80 µg/mL) Peak 1 = l-carnitine, and peak 5 = tartaric acid.
Figure 4
Figure 4
A chromatogram obtained from analyzing of the commercially available tablets.
Figure 5
Figure 5
Dissolution profile of l-carnitine in commercial tablets (n = 6).
See this image and copyright information in PMC

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