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Stability indicating thin-layer chromatographic determination of eslicarbazepine acetate as bulk drug: Application to forced degradation study | Abstract
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Abstract

Stability indicating thin-layer chromatographic determination of eslicarbazepine acetate as bulk drug: Application to forced degradation study

Author(s): Nikita V. Mali and Deepali A. Bansode

The objective of present work was to develop a validated stability indicating high performance thin layer chromatographic method (HPTLC) for estimation of eslicarbazepine acetate. The stationary phase used was precoated silica gel aluminium plates 60 F-254 with 250 μm thickness. The mobile phase used for separation was toluene: methanol: acetone (6: 2: 2: v/v/v) gave a resolved peak at (Rf value of 0.67 ± 0.02). Eslicarbazepine acetate was subjected to hydrolytic, oxidative, dry heat treatment and photo degradation. The drug was found to degrade in hydrolytic, oxidative, dry heat conditions and was found to be slightly degraded in photolytic conditions. All the peaks of degraded products were separated from the standard drug with significantly different Rf values of its degradants. The drug showed two degradant peaks in acidic medium at Rf value of 0.06± 0.02, 0.17± 0.02. In basic medium three degradant peaks at Rf value of 0.07± 0.02, 0.18±0.02, 0.70± 0.02). Oxidative hydrolysis showed three degradants which were resolved at Rf value of 0.05± 0.020, 0.16± 0.02, 0.19± 0.02. Dry heat degradation was observed with two resolved peaks at Rf value of 0.77± 0.02, 0.88± 0.02. Slight degradation was shown in photochemical degradation with one degradant at Rf value of 0.51± 0.02. The developed method can effectively separate the drug from its degradation products under accelerated degradation studies; it can be routinely employed as stability indicating method for eslicarbazepine acetate.