Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF SILDENAFIL IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

M. Gayathri Devi*, R. Parimala, P. V. Madhavi Latha, B. Nagamani, P. Uma Devi

ABSTRACT

A new RP-HPLC method for the quantitative determination of sildenafil was developed and validated as per ICH guidelines. The drugs were injected into Inertsil C18 column (250×4.6, 5 μm), maintained at ambient temperature and effluent monitored at 224 nm. The mobile phase consisted of Acetonitrile: Water (70:30 V/V). The flow rate was maintained at 1.0 ml/min. The calibration curve for Sildenafil was linear from 5-37.5μg/ml (r2 for sildenafil = 0.99). The proposed method was adequate, sensitive, reproducible, accurate and precise for the determination of Sildenafil in bulk and pharmaceutical dosage forms.

Keywords: Sildenafil, Linearity, Validation.


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