Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SILDENAFIL CITRATE AND BOSENTAN IN SYNTHETIC MIXTURE

Vishruti Maniar*, Prof. Puja Vyas, Prof. Krisna Kalsara and Dr. Umesh M. Upadhyay

ABSTRACT

Uv Spectroscopy method is simple and sensitive first order derivative method was developed for the simultaneous estimation of Bosentan and Sildenafil citrate Citrate in their synthetic mixture. Developed methods were successfully applied to synthetic mixture and assay were found to be 98.99% - 101.38% for Bosentan and 97.25% - 101.19% for Sildenafil citrate Citrate. Simple and sensitive RP-HPLC were developed for simultaneous estimation of Bosentan and Sildenafil citrate Citrate in their synthetic mixture. RP-HPLC method was developed using Shimpack ODS C18 column 25 cm (4.6 mm x 250mm, 5 um) as a stationary phase and Acetonitrile: Water (95:5 % V/V) as mobile phase. The flow rate was maintained at 1 ml/ min and detection was carried out at 299 nm where Bosentan (BOSE) and Sildenafil citrate (SILD)have significant absorbance. The retention times of Bosentan (BOSE) and Sildenafil citrate (SILD) was found to be 4.260 min and 5.072 min respectively. RP-HPLC method is linear by plotting a calibration curve over the concentration range of 15 - 75 µg/ ml for BOSE and 5- 25 µg / ml for SILD, respectively with R2 - 0.9981 for BOSE and 0.9996 for SILD. The method was found to be accurate, precise, specific, selective, repeatable, robust and reproducible.

Keywords: UV SPECTROSCOPY, RP-HPLC, SILDENAFIL CITRATE, BOSENTAN.