Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF NICERGOLINE IN BULK AND TABLET DOSAGE FORM.

*B. Varsha, G. Naga Sowjanya, A. Ajitha, V. Uma Maheswara Rao,
Ramya Sri. Sura

Abstract

A Rapid and Precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the estimation of Nicergoline, in its pure form as well as in its tablet dosage form. Chromatography was carried out on a Phenomenex Gemini C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol and Phosphate buffer (pH 6, adjusted with potassium dihydrogen phosphate) in the ratio of 70:30 v/v as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 289 nm. The retention time of the Nicergoline was 2.212 min respectively. The method produced linear responses in the concentration range of 10-50μg/ml of Nicergoline. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. Stability indicating studies were also carried out as per standard procedures.

Keywords: Nicergoline, RP-HPLC, stability indicating studies, validation, Tablet dosage form.