STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TERBINAFINE AND ITRACONAZOLE IN API AND TABLET DOSAGE FORM BY RP-HPLC
Vankayalapati Manjusha*, P. Sreenivasa Prasanna and K. Thejomoorthy
ABSTRACT
A simple, Accurate, precise method was developed for the simultaneous estimation of the Terbinafine and Itraconazole in tablet dosage form. Chromatogram was run through Phenomenex C18 4.6 x 250mm, 5?m. Mobile phase containing Buffer 0.01N Kh2po4: acetonitrile taken in the ratio 65:35v/v was pumped through column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 270 nm. Retention time of Terbinafine and Itraconazolewere found to be 2.221 min and 2.819min. %RSD of the Terbinafine and Itraconazole were and found to be 0.8 and 0.9 respectively. %Recovery was obtained as 100.36% and 100.70% for Terbinafine and Itraconazole respectively. LOD, LOQ values obtained from regression equations of Terbinafine and Itraconazole were 0.78,2.37 and 0.11, 0.34 respectively. Regression equation of Terbinafineis y =21293x + 9314.3, and y = 21074x + 5342.7 of Itraconazole 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.
[Full Text Article] [Download Certificate]