Journal of Chemistry

Journal of Chemistry / 2008 / Article

Open Access

Volume 5 |Article ID 682924 | https://doi.org/10.1155/2008/682924

B. Prasanna Kumar Reddy, Y. Ramanjaneya Reddy, "Validation and Stability Indicating RP-HPLC Method for the Determination of Sildenafil Citrate in Pharmaceutical Formulations and Human Plasma", Journal of Chemistry, vol. 5, Article ID 682924, 6 pages, 2008. https://doi.org/10.1155/2008/682924

Validation and Stability Indicating RP-HPLC Method for the Determination of Sildenafil Citrate in Pharmaceutical Formulations and Human Plasma

Received17 Mar 2008
Accepted10 May 2008

Abstract

A simple, selective, accurate reverse phase-high performance liquid chromatographic (RP-HPLC) method was developed and validated for the analysis of sildenafil citrate in pharmaceutical formulations. Chromatographic separation achieved isocratically on a C18 column (Use Inertsil C18, 5μ , 150 mm x 4.6 mm) utilizing a mobile phase of acetonitrile/phosphate buffer (70:30, v/v, pH 7.0) at a flow rate of 0.8 mL/m with UV detection at 228 nm. The retention time was 4.087. The method is accurate (99.15-101.85%), precise (intra-day variation 0.13-1.56% and inter-day variation 0.30-1.60%) and linear within range 0.1-30 μg/mL (R2=0.999) concentration and was successfully used in monitoring left over drug. The detection limit of sildenafil citrate at a signal-to-noise ratio of 3 was 1.80 ng/mL in human plasma while quantification limit in human serum was 5.60 ng/mL. The proposed method is applicable to stability studies and routine analysis of sildenafil citrate in pharmaceutical formulations as well as in human plasma samples.

Copyright © 2008 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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