Abstract
Stability indicating RP-UPLC photo diode array detector based method for determination of Dapagliflozin propanediol monohydrate (DPM) in active pharmaceutical ingredient (API) and in tablet dosage form (5mg dapagliflozin) has been developed and validated on Bridge Ethylene Hybride (BEH) C18 column (50mm × 2.1 mm, 1.7µm). Mobile phase composition was water: acetonitrile (60:40 v/v), flow rate 0.5ml/min and detection carried out at 223nm at column temperature 30ºC. Chromatographic separation achieved within 2 min with retention time 0.77 min. Linearity of the method was found over the concentration range of 25-75µg/ml (R2 = 0.9977). The degradation was carried out in five different stress conditions. The developed method was able to resolve peak of API from all generated peaks. Sufficient degradation was achieved in the range of 5.25 to 12.31%. The peak purity is acceptable, Method validation was performed as per ICH guideline Q2(R1).
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
