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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

Author(s): Archana Karnik*, Vrushali Tambe and B. S. Kuchekar
Department of Pharmaceutical Chemistry, SCES’s Indira College of Pharmacy, Pune 411033, 1Department of Pharmaceutical Chemistry, PES Modern College of Pharmacy, Pune 412105, 2Department of Pharmaceutical Chemistry, MAEER’s Maharashtra Institute of Pharmacy, Pune 411038, India

Correspondence Address:
Archana Karnik, Department of Pharmaceutical Chemistry, SCES’s Indira College of Pharmacy, Pune 411033, India, E-mail:

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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