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Madhuri, G. V.
- Stability-Indicating Method of Entacapone-Related Substances Using UPLC in Finished Dosage Form
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Authors
Affiliations
1 Department of Chemistry, GITAM University, Hyderabad 502 329, IN
1 Department of Chemistry, GITAM University, Hyderabad 502 329, IN
Source
Current Science, Vol 114, No 03 (2018), Pagination: 644-649Abstract
A rapid, specific, sensitive and robust method for entacapone-related substances in carbidopa, entacapone and levodopa film-coated tablet was developed using ACQUITY UPLC with BEH C18 column. Mobile phase (A), i.e. 0.1% orthophosphoric acid and mobile phase (B), i.e. acetonitrile with water in the ratio 75 : 25 (v/v) with gradient method were employed. The method was evaluated for identification of process impurities and unknown impurities. It has been validated according to ICH (Q2) R1 guidelines. The values of LOD and LOQ for impurity and entacapone were found to be 0.01% and 0.03% respectively. Degradation studies were carried out in peroxide, acid, alkali conditions and contribution to mass balance was established. It was stable under heat, light-exposed and humid conditions.Keywords
Entacapone-Related Substances, Dosage Form, Force Degradation Study, Liquid Chromatography.Full Text
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