Development and validation of liquid chromatography method for simultaneous estimation of miconazole and clobetasol and characterization of hydrolytic degradation products using liquid chromatography with tandem mass spectrometry
By: Karnik, Archana
.
Contributor(s): Tambe, Vrushali.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2022Edition: Vol.84(2), Mar-Apr.Description: 268-280p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: A reverse phase high performance liquid chromatography method was developed to estimate miconazole
nitrate and clobetasol propionate simultaneously from a cream formulation. The developed method was
validated as per International council for harmonisation guidelines. The proposed method was effectively
applied for the characterization of degradation products formed under hydrolytic stressed conditions. The
major degradants formed by hydrolysis of both the analytes were separated, identified and characterized.
Both drugs were found susceptible to acid and base hydrolytic conditions while were stable under neutral
hydrolysis. The liquid chromatography with tandem mass spectrometry studies were further carried out
on stressed samples that provided the accurate masses of drug and their degradation products. The mass
spectral data and fragmentation patterns were further explored to characterize the degradants and assign
structures to them. Total nine degradants were characterized and the degradation pathways for both the
drugs were proposed.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2022-2168 |
A reverse phase high performance liquid chromatography method was developed to estimate miconazole
nitrate and clobetasol propionate simultaneously from a cream formulation. The developed method was
validated as per International council for harmonisation guidelines. The proposed method was effectively
applied for the characterization of degradation products formed under hydrolytic stressed conditions. The
major degradants formed by hydrolysis of both the analytes were separated, identified and characterized.
Both drugs were found susceptible to acid and base hydrolytic conditions while were stable under neutral
hydrolysis. The liquid chromatography with tandem mass spectrometry studies were further carried out
on stressed samples that provided the accurate masses of drug and their degradation products. The mass
spectral data and fragmentation patterns were further explored to characterize the degradants and assign
structures to them. Total nine degradants were characterized and the degradation pathways for both the
drugs were proposed.
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