Stability Indicating Assay Method Development of Fingolimod

Language: English

Published by LAP LAMBERT Academic Publishing Okt 2017, 2017

3659692751 / 9783659692758

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Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.

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This item is printed on demand - it takes 3-4 days longer - Neuware -Stress testing of Fingolimod capsules was carried out under acidic, alkaline, peroxide, photolytic, and dry heat conditions. The stressed sample and standard drug were subjected to chromatographic separation and the conditions required for resolving the drug peak from any potential degradation products were optimized. The HPLC analysis of Fingolimod Capsules was carried out using X-Bridge (250mm x 4.6 mm, 5µm) during the stress studies Fingolimod Capsules were found to be stable degrade under acidic, alkaline, peroxide, photolytic and heat conditions. The degradation products and tablet excipients were well resolved from the drug using mobile phase comprising of Buffer:ACN (30:70v/v). The detection wavelength was 220 nm. The developed method was validated as per ICH Guide lines. The method was found to be accurate, precise, robust and linear in the range of 2-14µg/ml. Accuracy was calculated at three levels:50 %, 100%, 150% and recovery was found to be between 95-105%. It can be concluded that the HPLC method developed for Fingolimod Capsules is capable of discriminating between the drug and degradation products. 100 pp. Englisch. …

Seller Inventory # 9783659692758

Title
Stability Indicating Assay Method Development of Fingolimod
Author
Sunil Shingade
Publisher
LAP LAMBERT Academic Publishing Okt 2017
Publication year
2017
Condition
Neu
Dust jacket
Dust Jacket Included
Binding
Taschenbuch
Language
English
ISBN 10
3659692751
ISBN 13
9783659692758
Item weight
167 grams
Dimensions
220x150x6 mm

BuchWeltWeit Ludwig Meier e.K.

Bergisch Gladbach, Germany

5-star seller

AbeBooks seller since January 11, 2012

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BuchWeltWeit Ludwig Meier e.K.

Germany