Abstract

DEVELOPMENT AND VALIDATION OF NEW HPLC METHOD FOR THE QUANTITATIVE ESTIMATION OF SILODOSIN IN BULK AND PHARMACEUTICAL FORMULATION

Karazgi Kishwar Jahan*, Malipatil S.M

ABSTRACT

A new, rapid, accurate, precise and economical method has been developed for the quantitative estimation of Silodosin in bulk as well as dosage form. Isocratic elution with X-Terra C18 (4.6 x 150mm, 3.5 m) column was performed, the mobile phase consist of a mixture of ortho phosphoric acid buffer, methanol (60%: 40% v/v) which was pumped at a flow rate of 1 ml/ min. The eluent was detected by UV detector at 269 nm. The retention time was 1.583 min. The method was linear between the range of 10-30 μg/ml with correlation coefficient of 0.999. The proposed method was validated as per the ICH guidelines and it can be concluded that the developed method is precise, accurate, economical, rugged, and robust and can be utilized for the routine analyses of Silodosin in bulk and dosage form.

Keywords: Silodosin, isocratic, ICH guidelines, validation.