Wed, 18 Oct 2017

Determination of Sildenafil Citrate In Pharmaceutical Dosage Forms by Reverse Phase High Performance Liquid Chromatography Method

M.Kumar*1, S.Alexandar1,  M.V.Kumudhavalli1, R.Margret Chandira1,  Palanisamy.P1

1.Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s University, Salem (D.T), Tamil Nadu (State), India.


ABSTRACT

The main aim of the present study was to develop and validate a simple, rapid and sensitive assay method for sildenafil citrate in pharmaceutical dosage forms by reverse phase high performance liquid chromatography method. Determination Of Sildenafil Citrate was determined by reverse phase HPLC using Potassium dihydrogen phosphate Buffer (pH 7.0):ACN(45:55) and column  Inertsil ODS-3V 5μ (150*4.6mm) as a stationary phase and  the chromatogram of Sildenafil Citrate has shown in figure 10 and peak was observed at 228 nm which was selected as a wavelength for quantitative estimation. After development of the method, it was validated for system suitability, specificity, linearity, precision, accuracy, robustness and solution stability studies. The results system suitability was found to be within the limits. The limit were not more than RSD <2%. Precision RSD was found to be 0.43 for Sildenafil Citrate. The precision was found to be within the limits. The limit were not more than RSD <2%. Precision RSD was found to be 0.3 for Sildenafil Citrate. The accuracy was found that recovery value of pure drug from the reanalyzed solution of formulation were between 98.0 % to 102% which indicates that the method is accurate and also reveals that commonly used excipients. Theoretical plate for Sildenafil Citrate was found to be not less than 4500. Retention time was nearer to 5.0. In Robustness parameter in both conditions the R.S.D. was less than 2%. (-10 and +10) Hence this method was better for pharmaceutical formulations Analysis. In Solution Stability parameter the R.S.D. was less than 2%. Both Standard and Sample solution was stable up to 48 Hrs.

Keywords: Sildenafil Citrate, system suitability, specificity.


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