Author(s): Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna

Email(s): kalyani.lingamaneni@gmail.com

DOI: 10.52711/0974-360X.2021.00772   

Address: Kalyani Lingamaneni*, Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Analysis & Quality Assurance, Gandhi Institute of Technology and Management (Deemed to be University), GITAM Institute of Pharmacy, Visakhapatnam, Andhra Pradesh-530045, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 8,     Year - 2021


ABSTRACT:
A new stability-indicating RP-UFLC method has been developed for the estimation of Bosentan in pharmaceutical dosage forms and the method was validated. Bosentan is used to lower the high blood pressure in lungs (pulmonary arterial hypertension). Bosentan acts by blocking the actions of endothelin -1and thereby lowers the blood pressure. Mobile phase mixture consisting of sodium acetate (pH 5.0) buffer solution and acetonitrile (50: 50 v/v) with flow rate 0.7 mL/min were the optimized chromatographic conditions (Detection wavelength 254 nm) for the present study. Linearity was observed in the concentration range of 0.1–100 µg/mL (R2 = 0.9998) with regression equation y = 126698 x – 392.49. The LOQ was found to be 0.08964 µg/mL and the LOD was found to be 0.02913 µg/mL. Stress degradation studies such as acidic, alkaline, oxidation, photolysis and thermal degradations were performed by exposing Bosentan and finally the proposed method was validated as per ICH guidelines. The assay of Bosentan was conducted by applying the proposed method to the marketed formulations. The proposed method is simple, specific, precise, and accurate and can be applied for the estimation of pharmaceutical formulations.


Cite this article:
Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna. Development and validation of a new stability indicating RP-UFLC method for the estimation of Bosentan. Research Journal of Pharmacy and Technology. 2021; 14(8):4445-1. doi: 10.52711/0974-360X.2021.00772

Cite(Electronic):
Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna. Development and validation of a new stability indicating RP-UFLC method for the estimation of Bosentan. Research Journal of Pharmacy and Technology. 2021; 14(8):4445-1. doi: 10.52711/0974-360X.2021.00772   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-8-78


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