Photodegradation profiling of nitrendipine: evaluation of active pharmaceutical ingredient, tablets and its altered forms

Direct enantiomer separation of denopamine (DP, active form: R (-)-form), which is an optically active and an orally administrable cardiotonic agent, was investigated by HPLC with β-cyclodextrin (β-CD) immobilized chiral stationary phases (CSPs). Successful enantiomer separation under the reversed-phase mode was achieved by a β-CD having a phenyl moiety immobilized CSP with large resolution within 10 min. Optical purity testing and assay of tablets by the HPLC method developed were validated for specificity, linearity, and recovery. Validation results indicate the method is accurate and has a good linearity and sensitivity. Limit of detection and limit of quantitation of the minor enantiomer were 0.01% and 0.03%, respectively. Assay of DP tablets 5 mg by the internal standard method was also successfully achieved within 10 min. Further, photostability of DP was evaluated by this chiral HPLC method and the reversed-phase HPLC with an ODS column. Chemical structures of two photoproducts generated in an aqueous media were determined by LC-MS/MS, showing these were p-hydroxybenzaldehyde and 3,4-dimethoxyphenethylamine. Other than these two main photoproducts, low level (0.17%) of the minor enantiomer was detected.

show abstract

Chiral Inversion Studies of Denopamine by HPLC with a β-Cyclodextrin Derivative Immobilized Chiral Column

FUJISAWA,

MATSUI,

KAWABATA

et al. 2024

Chromatography

View full text Add to dashboard Cite

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

Contact Info

customersupport@researchsolutions.com

10624 S. Eastern Ave., Ste. A-614

Henderson, NV 89052, USA

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Blog Terms and Conditions API Terms Privacy Policy Contact Cookie Preferences Do Not Sell or Share My Personal Information

Made with 💙 for researchers

Part of the Research Solutions Family.

Photodegradation profiling of nitrendipine: evaluation of active pharmaceutical ingredient, tablets and its altered forms

Cited by 4 publications

References 33 publications

Development of the Analysis of Lysophospholipids and Photo-sensitive Pharmaceuticals Based on LC-MS/MS for Elucidation of Their Behaviors

Development of the Analysis of Lysophospholipids and Photo-sensitive Pharmaceuticals Based on LC-MS/MS for Elucidation of Their Behaviors

Development of HPLC Optical Purity Testing Method of Denomapine and Application to Its Photostability

Chiral Inversion Studies of Denopamine by HPLC with a β-Cyclodextrin Derivative Immobilized Chiral Column

Contact Info

Product

Resources

About