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Validated HPTLC Methods for Quantification of Mexiletine Hydrochloride in a Pharmaceutical Formulation

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Two simple, accurate, and precise HPTLC methods have been established for the determination of mexiletine hydrochloride, an antiarrhythmic agent, in Mexicord capsules. Analyses were performed in horizontal chambers on RP C18F254s and normal-phase amino (NH2) HPTLC precoated plates with the mobile phases tetrahydrofurancitrate buffer, pH 4.45 (3 + 7, v/v) and chloroformtetrahydrofuranhexaneethylamine (3 + 2 + 5 + 0.1, v/v/v/v), respectively. The plates were developed for a distance of 40 mm in both cases. Densitometric measurements were achieved in the UV mode at 217 nm based on peak areas with semilinear calibration curves (R2 0.97) in the concentration range 0.58.0 g/spot for the NH2 and C18 HPTLC methods. The elaborated chromatographic methods were validated in accordance with International Conference on Harmonization guidelines in terms of linearity, accuracy (99.64 for NH2 and 99.53 for C18), precision (intraday RSD 1.16 and 2.71, respectively), sensitivity (LOD 0.1 g/spot for both systems), and specificity.
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Document Type: Research Article

Affiliations: 1: Medical University of Lublin, Department of Medicinal Chemistry, Jaczewskiego 4, 20-090 Lublin, Poland and School of Economics and Law, Faculty of Health Sciences, Jagielloska 109A, 25-734, Kielce, Poland. 2: Medical University of Lublin, Department of Medicinal Chemistry, Jaczewskiego 4, 20-090 Lublin, Poland.

Publication date: May 1, 2010

More about this publication?
  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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