Abstract

A NEW IMPROVED STABILITY-INDICATING RP-HPLC METHOD FOR DETERMINATION OF SILDENAFIL CITRATE IN SOFT GELATIN CAPSULE DOSAGE FORM

Mythili Arthanari*, Keerthana and Senthil Kumar Raju

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Abstract

A simple, rapid, selective, accurate Reverse Phase-High Performance Liquid Chromatographic (RP-HPLC) method was developed, validated and stability studies for the analysis of sildenafil citrate in pharmaceutical formulations. An isocratic reverse phase high performance liquid chromatographic was developed for sildenafil citrate soft gelatin capsule dosage forms. The mobile phase was ammonium acetate and potassium hydroxide in the proportion of 1:1 v/v. The chromatographic method was performed on water reliant C18, 15 cm×4.6 mm, 5μm column at a flow rate of 1.0 ml/min with UV detection at 228 nm. The retention time was 4.5mins. The method was accurate 99-101%, precision 1.006%, linear within range 0.1-32 μg/mL (R2 =0.999) concentration. The number of theoretical plates of sildenafil citrate was 11325 respectively. The tailing factor of sildenafil citrate was 1.12. Different analytical performance was determined according to International Conference on Harmonization ICH Q2B guidelines.

Keywords: Sildenafil Citrate, Soft Gelatin Capsules, RP-HPLC, Method Validation, Stability Study.