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%.
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References
USP DI (2005) Drug Information for the Health Care Professional, 25th edn. The United States Pharmacopeial Convention Inc., Rockville, MD, sildenafil (systemic) monograph
Mosby’s Drug Consult (2005) 15th edn. Elsevier Inc., sildenafil monograph
Wespes E, Amar E, Hatzichristou D, Montorsi F, Pryor J, Vardi Y (2002) Eur Urol 41:1–5. doi:10.1016/S0302-2838(01)00008-2
Stief CG, Uckert S, Becker AJ, Truss MC, Jonas U (1998) J Urol 159:1390–1396. doi:10.1016/S0022-5347(01)63622-X
Bayot J (2005) Int Herald Tribune, p 15
Reepmeyer JC, Woodruff JT (2006) J Chromatogr A 1125:67–75. doi:10.1016/j.chroma.2006.05.018
Zou P, Oh SS-Y, Hou P, Low M-Y, Koh H-L (2006) J Chromatogr A 1104:113–122. doi:10.1016/j.chroma.2005.11.103
Zhu X, Xiao S, Chen B, Zhang F, Yao S, Wan Z et al (2005) J Chromatogr A 1066:89–95. doi:10.1016/j.chroma.2005.01.038
Rodríguez Flores J, Berzas Nevado JJ, Castañeda Peñalvo G, Mora Diez N (2004) J Chromatogr B Analyt Technol Biomed Life Sci 811:231–236
Gratz SR, Flurer CL, Wolnik KA (2004) J Pharm Biomed Anal 36:525–533. doi:10.1016/j.jpba.2004.07.004
Stability ICH Testing of New Drug Substances and Products Q1A (R2) (2003) International Conference on Harmonization, IFPMA, Geneva
Singh S, Bakshi M (2000) Pharm Tech On-line 24:1–14
ICH Photo stability Testing of New Drug Substances and ProductsQ1B, International Conference on Harmonization, IFPMA, Geneva (1996)
Bakshi M, Singh S (2002) J Pharm Biomed Anal 28:1011–1040. doi:10.1016/S0731-7085(02)00047-X
Singh S, Singh B, Bahuguna R, Wadhwa L, Saxena R (2006) J Pharm Biomed Anal 41:1037–1040. doi:10.1016/j.jpba.2006.01.030
Drug stability principles and practices (2000) 3rd edn. Edited by Carstensen T, Rhodes CT
Validation of compendial methods (2008) The United States Pharmacopeia, 31st edn. USP31
ICH Validation of analytical procuderes: Text and methodology Q2 (R1), International Conference on Harmonization, IFPMA, Geneva (2005)
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Subba Rao, D.V., Surendranath, K.V., Radhakrishnanand, P. et al. A Stability Indicating LC Method for Vardenafil HCl. Chroma 68, 829–835 (2008). https://doi.org/10.1365/s10337-008-0766-4
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DOI: https://doi.org/10.1365/s10337-008-0766-4