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Determination of Nisoldipine and Its Impurities in Pharmaceuticals

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Abstract

A method has been established for separation of nisoldipine and impurities, for example reactants, products of side-reactions, and photodegradation products, by HPTLC on LiChrospher Si 60 F254s plates with detection at 280 nm. The mobile phase, cyclohexane–ethyl acetate–toluene, 7.5:7.5:10 (v/v), enables acceptable resolution of nisoldipine, in large excess, and possible impurities. Regression coefficients (r ≥ 0.997), recovery (98–108%), and determination limit (0.02–0.2%) were validated and found to be satisfactory. The method is convenient for quantitative analysis and purity control of nisoldipine in its raw material and dosage forms.

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Authors and Affiliations

  1. Faculty of Pharmacy, Institute of Pharmaceutical Chemistry and Drug Analysis, P.O. Box 146, 11000, Belgrade, Serbia and Montenegro

    D. Agbaba & K. Vucicevic

  2. A.D. Zdravlje, Pharmaceutical and Chemical Industry, 16000, Leskovac, Serbia and Montenegro

    V. Marinkovic

Authors
  1. D. Agbaba
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  2. K. Vucicevic
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  3. V. Marinkovic
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Correspondence to D. Agbaba.

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Agbaba, D., Vucicevic, K. & Marinkovic, V. Determination of Nisoldipine and Its Impurities in Pharmaceuticals. Chromatographia 60, 223–227 (2004). https://doi.org/10.1365/s10337-004-0335-4

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  • DOI: https://doi.org/10.1365/s10337-004-0335-4

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