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Stability-Indicating Method of Entacapone-Related Substances Using UPLC in Finished Dosage Form


Affiliations
1 Department of Chemistry, GITAM University, Hyderabad 502 329, India
 

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.
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  • Stability-Indicating Method of Entacapone-Related Substances Using UPLC in Finished Dosage Form

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Authors

Naresh Konduru
Department of Chemistry, GITAM University, Hyderabad 502 329, India
Rambabu Gundla
Department of Chemistry, GITAM University, Hyderabad 502 329, India
Naresh Kumar Katari
Department of Chemistry, GITAM University, Hyderabad 502 329, India
G. V. Madhuri
Department of Chemistry, GITAM University, Hyderabad 502 329, India

Abstract


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.

References





DOI: https://doi.org/10.18520/cs%2Fv114%2Fi03%2F644-649