Abstract

NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ANTI-ASTHMATIC DRUG (SERATRODAST) IN BULK DRUG AND DOSAGE FORM

Kripa Shrestha*, T. Sreenivasa Rao, Dr. C. Sreedhar and Rikshaya Tamang

ABSTRACT

A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Seratrodast in tablet dosage form. Agilent Eclipse Plus C8 column, 4.6x150mm, 5μm particle size, with mobile phase consisting of Acetonitrile: Tri-fluoro Acetic Acid (TFA) in the ratio of 30:70% v/v was used. The flow rate was 1.0 ml/min and the effluents were monitored at 266 nm. The retention time was 3.4 mins. The detector response was linear in the concentration of 500ng-16mcg/ml and gave an average correlation factor of 0.9998 for Seratrodast. The respective linear regression equation being Y= 2E+06x+534028. The limit of detection and limit of quantification was 0.06mcg/ml and 0.204mcg/ml respectively. The method showed good recoveries and relative standard deviations of intra and inter day assay less than 2. This method can be easily and conveniently used for routine analysis of Seratrodast in bulk and tablet dosage forms.

Keywords: Seratrodast, RP-HPLC, Method Development, Validation, Ultra-Visible Spectrophotometry.