Stability Indicating Method Devleopment and Validation for The Estimation of Sodium Phenyl Butyrate and Taurursodilol by Using Rp-HPLC

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Sodium phenylbutyrate and Taurursodiol in bulk and pharmaceutical dosage form. Chromatogram was run through Cogent RP C18 150 x 4.6 mm, 5 m. Mobile phase containing Buffer 0.01N Sodium hydrogen phosphate : Acetonitrile taken in the ratio 80:20 was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was 0.01N Sodium hydrogen phosphate buffer. Temperature was maintained at 26.0°C. Optimized wavelength selected was 284.0 nm. Retention time of Sodium phenylbutyrate and Taurursodiol were found to be 2.276 min and 2.886 min. %RSD of the Sodium phenylbutyrate and Taurursodiol were and found to be 0.9% and 0.4% respectively. %Recovery was obtained as 99.91% and 99.98% for Sodium phenylbutyrate and Taurursodiol respectively. LOD, LOQ values obtained from regression equations of Sodium phenylbutyrate and Taurursodiol were 0.37, 1.12 and 0.12, 0.35 respectively.

%Assay was obtained as 99.84% and 99.39% for Sodium phenylbutyrate and Taurursodiol respectively. Regression equation of Taurursodiol is y = 13519x + 15827, y

= 13758x + 2738.3 of Sodium phenylbutyrate. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries