Stability Indicating Photodiode Array Detector Based Estimation of Dapagliflozin Propanediol Monohydrate in API and Tablet Dosage Form by RP-UPLC

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 (...

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Veröffentlicht in:Research journal of pharmacy and technology Jg. 14; H. 9; S. 4635 - 4639
Hauptverfasser: Patel, Ashok B., Vaghasiya, Ekta H., Dudhatra, Amit R., Vyas, Amitkumar J., Patel, Ajay I., Patel, Nilesh K., Jadav, Hina M.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Raipur A&V Publications 01.09.2021
Schlagworte:
Accuracy
Antidiabetics
Chromatography
Diabetes
Drug dosages
Sensors
ISSN:0974-3618, 0974-360X, 0974-306X
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Zusammenfassung: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).
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ISSN:0974-3618
0974-360X
0974-306X
DOI:10.52711/0974-360X.2021.00805