A Novel Method Development, Validation and Study of Forced Degradation Behaviour on Prazosin and Polythiazide in Combined Phramaceutical Dosage form by UPLC –TUV Method

Anandathangadurai S, Kamalakannan D,Sambathkumar R, Dr. GauriUgal 1

8th WCPSDM.2021. APR.Published Online 18 APR 2021

Abstract : A simple, accurate, precise and economical method was developed for the simultaneous estimation of the Prazosin and Polythiazide in pharmaceutical dosage form by ultra-performance liquid chromatography (UPLC) using tunable ultraviolet (TUV) detector. The separation was achieved on a BEH C18 column (2.1 mm X 100 mm, 1.7 μm,) at a wavelength of 260 nm, using a mobile phase potassium dihydrogen phosphate and acetonitrile (60:40 V/V) in an isocratic elution mode at a flow rate of 0.3 mL/min. The retention time for Prazosin and Polythiazide was found to be 0.843 min and 1.579 min, respectively. The percentage RSD of the Prazosin and Polythiazide were and found to be 1.2 and 0.9 respectively and the percentage recovery was obtained at 99.92% and 100.67%. The LOD, LOQ values were obtained from regression equations of Prazosin and Polythiazide were 0.228 ppm, 0.01 ppm and 0.0692 ppm, 0.03 ppm respectively. The regression equation of Prazosin is y = 36126x + 9204.2 and Polythiazide is y =29748x + 2043.1. The developed method was found to be simple, accurate, precise and cost-effective. The forced degradation studies showed that the degradants are within the limit and excipients were observed. Hence, the developed method was suitable for quality-control laboratories for quantitative analysis of both in bulk and combined dosage form.