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ZENODO
Article . 2017
License: CC BY
Data sources: ZENODO
ZENODO
Article . 2017
License: CC BY
Data sources: Datacite
ZENODO
Article . 2017
License: CC BY
Data sources: Datacite
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METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES FOR DETERMINATION OF EBASTINE IN TABLET DOSAGE FORM BY USING RP-HPLC

Authors: Y. Naveen Kumar; B. Divya; Dr. J Sreekanth;

METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES FOR DETERMINATION OF EBASTINE IN TABLET DOSAGE FORM BY USING RP-HPLC

Abstract

Abstract RP- HPLC method is developed for estimation of Ebastinein the tablet dosage form. Employing a simple and stability-indicating HPLC method, using stress degradation studies, drug was well separated from the degradantswith good peak resolution. Mobile phasewas prepared with using ortho phosphoric acid and diethylaminebuffer, methanol and acetonitrile in the ratio of 10: 70: 20 v/v. The chromatographic separation was achieved by using Kromasil 100 C8, 250x4.6mm, 5 µLat a flow rate of 1.0 mL/min. the detection wavelength selected is 210 nm.The drug was subjected for degradation studies acid degradation, base degradation, peroxide degradation, photolytic degradation and thermal degradation. Ebastine was eluted at a retention time of 6 minutes. the developed method is used for assay of orodispersible tablets containing Ebastine. The percentage assay was found to be 99.82 %. Linearity of the drug for the developed method was found within a range of 80 µg/ml to 800 µg/ml. the method was precise with % RSD values below 2. The method is found accurate with % recoveries of 99.3 to 100.6 %. The method was validated as per ICH guidelines. Validation results confirm the applicability of the developed method for quality analysis and stability studies of the regular product on the manufacturing stream. Keywords: Ebastine; degradation; RP-HPLC; method development; Validation

Keywords

Ebastine, RP-HPLC, Validation, method development, degradation

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average