DOI: 10.21276/ajptr
Thu, 23 May 2019

A stability indicating RP-UPLC method for estimation of Bosentan and its impurities in bulk drugs and pharmaceutical dosage forms.


Srihari Molleti1*, Vinay Rao2, K. N. Jayaveera3

1.Daewoong pharmaceuticals India private limited, Balanagar, Hyderabad India.

2.Malla reddy college of pharmacy, Hyderabad

3.Department of chemistry, JNT University, Anantapur. India



This study is aimed at Developing and validating an UPLC method for Bosentan and its related substances that might coexist in bulk drugs and its tablet formulations as impurities that may originate from synthesis process or degradation. A chromatographic system consisting Waters Acquity UPLC HSS PFP, 2.1x 50mm (2.5 µm) column, mobile phase of 0.02M KH2PO4with pH 2.0 as Buffer phase and Acetonitrile: Methanol in 1:1 ratio as organic phase, with gradient elution at flow of 0.6 mL/min and UV detector set at 220 nm has shown a good chromatographic separation for Bosentan and its related substances. The developed method was validated as per ICH Guidelines and shown equivalency with API Vendor method. The developed UPLC method has run time of only 13 minutes making the method productive and may be applied for Quality control Testing.

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