A NEW VALIDATED METHOD FOR THE ESTIMATION OF SPARSENTAN IN BULK AND PHARAMCEUTICAL DOSEAGE FORM BY - RPHPLC

Abstract

The stability of innovative drug formulation and the development of appropriate stability-indicating methodologies are top priorities in contemporary pharmaceutical studies. The current work has developed and validated a thorough stability-indicating HPLC-PDA method for the determination of Sparsentan, a developing and novel endothelin and angiotensin II receptor antagonist, to reduce levels of protein in the urine (proteinuria) in patients who have a kidney disease called primary immunoglobulin A nephropathy (IgAN), The stability of Sparsentan was examined under different stress conditions. Sparsentan was found to be susceptible to Acid degradation. effective separation of Sparsentan and its induced degradation products was achieved using isocratic elution mode on Discovery C18 150 x 4.6 mm, 5m maintained at 26.5 °C. The mobile phase used was comprised of 80.0 mm 0.1% OPA buffer (pH 2.8 ± 0.05) and acetonitrile (20 by volume), delivered at flow rate of 1.0 mL/min. The photo diode array signal for Sparsentan was monitored at 245.0 nm over a concentration range of 10–60 μg/mL, it is obvious that the recommended method is precise, dependable, economical, and time-saving. Because of this, it can be used for routine quality assurance and stability testing of Sparsentan in tablet form.