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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  • 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