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Stability-Indicating LC Method for the Determination of Lacidipine in Tablets. Application to Degradation Kinetics and Content Uniformity Testing

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Abstract

A simple, stability-indicating, reversed-phase liquid chromatographic method was developed for the determination of lacidipine in the presence of its degradation products. The analysis was carried out using a 150 mm × 4.6 mm i.d., 5 μm particle size Nucleodur MN-C18 column. Mobile phase containing a mixture of acetonitrile and 0.02 M phosphate buffer (70:30) at pH = 5.0 was pumped at a flow rate of 1 mL min−1 with UV-detection at 254 nm. The method showed good linearity in the range of 0.06–15 μg mL−1 with a limit of detection (S/N = 3) of 0.016 μg mL−1 (3.5 × 10−8 M). The suggested method was successfully applied for the analysis of lacidipine in bulk and in commercial tablets with average recoveries of 100.19 ± 0.81% and 100.05 ± 0.69%, respectively. The results were favorably compared to those obtained by a reference method. The suggested method was utilized to investigate the kinetics of alkaline, acidic, peroxide and photo-induced degradation of the drug. The apparent first-order rate constant, half-life times and activation energies of the degradation process were calculated. The pH profile curve was derived. The proposed method was successfully applied to the content uniformity testing of tablets.

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Authors and Affiliations

  1. Department of Analytical Chemistry, Faculty of Pharmacy, University of Mansoura, Mansoura, 35516, Egypt

    Fathalla Belal, Amina Elbrashy, Manal Eid & Jenny Jeehan Nasr

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  1. Fathalla Belal
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  2. Amina Elbrashy
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  3. Manal Eid
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  4. Jenny Jeehan Nasr
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Correspondence to Manal Eid.

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Belal, F., Elbrashy, A., Eid, M. et al. Stability-Indicating LC Method for the Determination of Lacidipine in Tablets. Application to Degradation Kinetics and Content Uniformity Testing. Chroma 69, 1201–1209 (2009). https://doi.org/10.1365/s10337-009-1067-2

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