Asian Journal of Pharmaceutical Analysis

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Stability Indicating High Performance Liquid Chromatographic Assay for the Determination of Sildenafil Tartrate


Affiliations
1 Department of Chemistry, Institute of science, GITAM University, Visakhapatnam, Andhra Pradesh, India
     

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A simple, fast, accurate and specific reverse phase high pressure liquid chromatographic (HPLC) method has been developed for simultaneous determination of Sildenafil base and its impurities in the Sildenafil Tartrate (API). The method was developed by reversed phase chromatography equipped with C18 (100 × 4.6 nm × 5.0 nm) column using mobile phase of (0.1%) formic acid and methanol (30:70 ratio) with a flow rate of 0.5 ml/min with ultraviolet detector configured at 290nm. The method was validated as per ICH guidelines.

Keywords

Sildenafil Tartrate, HPLC, Stability Indicating, Method Development, Validation.
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  • Liu YM, Yang HC, Miao J.R. ‘’Reversed-phase HPLC determination of Sildenafil citrate tablets. Yaowu. Fenxi. Zazhi 2000; 20: 61–62.

  • Lee M, Min D, “Determination of Sildenafil citrate in plasma by high-performance liquid chromatography and a case for the potential interaction of grape fruit juice with Sildenafil citrate”. Ther. Drug Monit, 2001; 23(1):21-26.

  • Reddy BPK, Reddy YR, “Validation and stability indicating RP-HPLC method for the determination of Sildenafil citrate in pharmaceutical formulation and human plasma” E-J Chem 2008; 5:1117-1122.

  • Draghmen N, Al-omari M, Badwan AA, Jaber AM, “Determination of Sildenafil citrate and related substances in the commercial products and tablet dosage form using HPLC’’. J Pharm Biomed Ana 2001; 25:483-492.

  • Reddy BP, Jaya prakash M, Sivaji K, Reddy SV, Reddy S V, “Validation and stability indicating RP-HPLC method for the determination of Sildenafil citrate in pharmaceutical formulations’’. Int J Applied Bio Pharm Tech 2010;1:104-111.

  • Kuchekar BS, Thakkar SV, Chothe PP, Hiremath MR, Shinde DB, “Spectrophotometric estimation of Sildenafil citrate in tablets”. Ind J Pharma Sc 2005;1:749-751.

  • Thangabalan B, Vadivel K, Sowjanya K, Tejaswi G, “Quantitative spectrophotometric determination of Sildenafil citrate in tablet formulation using urea as hydrotropic solubilizing agent”. Res J Pharm Tech 2011; 2(2); 235-239.


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  • Stability Indicating High Performance Liquid Chromatographic Assay for the Determination of Sildenafil Tartrate

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Authors

O. S. S. Chandana
Department of Chemistry, Institute of science, GITAM University, Visakhapatnam, Andhra Pradesh, India
R. Ravichandra Babu
Department of Chemistry, Institute of science, GITAM University, Visakhapatnam, Andhra Pradesh, India

Abstract


A simple, fast, accurate and specific reverse phase high pressure liquid chromatographic (HPLC) method has been developed for simultaneous determination of Sildenafil base and its impurities in the Sildenafil Tartrate (API). The method was developed by reversed phase chromatography equipped with C18 (100 × 4.6 nm × 5.0 nm) column using mobile phase of (0.1%) formic acid and methanol (30:70 ratio) with a flow rate of 0.5 ml/min with ultraviolet detector configured at 290nm. The method was validated as per ICH guidelines.

Keywords


Sildenafil Tartrate, HPLC, Stability Indicating, Method Development, Validation.

References