Determination of nisoldipine and its impurities in pharmaceuticals
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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 F-254s 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 greater than or equal to 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.
Keywords:thin-layer chromatography / nisoldipine and impurities / pharmaceutical preparations
Source:Chromatographia, 2004, 60, 3-4, 223-227
- Springer Heidelberg, Heidelberg