Chromatographia

, Volume 68, Issue 9–10, pp 829–835 | Cite as

A Stability Indicating LC Method for Vardenafil HCl

  • D. V. Subba Rao
  • K. V. Surendranath
  • P. Radhakrishnanand
  • M. V. Suryanarayana
  • P. Raghuram
Full Short Communication

Abstract

A simple, sensitive gradient RP-LC assay method has been developed for the quantitative determination of vardenafil HCl in bulk drug and in pharmaceutical dosage forms, used to treat erectile dysfunction. The developed method is also applicable for the related substances determination. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination delivered in a gradient mode and quantification was carried out using ultraviolet detection at a flow rate of 1.0 mL min−1. In the developed LC method the resolution between vardenafil and its four potential impurities was found to be greater than 3.0. Regression analysis shows an r 2 value (correlation coefficient) greater than 0.99 for vardenafil and its four impurities. This method was capable of detecting all four impurities of vardenafil at a level of 0.009% with respect to test concentration of 1.0 mg mL−1 for a 10 μL injection volume. The method has shown good and consistent recoveries for vardenafil (98.4–100.6%) and its four impurities (93.5–106.2%). The test solution was found to be stable in the diluent for 48 h. Mass balance was found close to 99.4%.

Keywords

Column liquid chromatography Stability indicating study Vardenafil HCl 

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Copyright information

© Vieweg+Teubner | GWV Fachverlage GmbH 2008

Authors and Affiliations

  • D. V. Subba Rao
    • 1
  • K. V. Surendranath
    • 1
  • P. Radhakrishnanand
    • 1
  • M. V. Suryanarayana
    • 2
  • P. Raghuram
    • 3
  1. 1.United States Pharmacopeia-India Private Limited, Reference Standard LaboratoryHyderabadIndia
  2. 2.Dr. Reddy’s Laboratories LimitedHyderabadIndia
  3. 3.Hetero Labs LtdHyderabadIndia

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