Stability Indicating Assay Method Development of Fingolimod - Softcover

Shingade, Sunil; Naik, Pooja

Softcover

ISBN 10: 3659692751 ISBN 13: 9783659692758

Verlag: LAP LAMBERT Academic Publishing, 2017

Inhaltsangabe

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.

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Über die Autorin bzw. den Autor

Dr. Sunil G. Shingade obtained his M. Pharm. degree from Rajiv Gandhi University of Health Sciences, Bangalore, India and Ph. D. in Pharmacy from North Maharashtra University, Jalgaon, India. He is Assistant Professor of Pharmaceutical Chemistry department at PES's Rajaram and Tarabai Bandekar College of Pharmacy, Goa.

Details zur Ausgabe

• Verlag: LAP LAMBERT Academic Publishing
• Erscheinungsdatum: 2017
• Sprache: Englisch
• ISBN 10: 3659692751
• ISBN 13: 9783659692758
• Einband: Taschenbuch
• Anzahl der Seiten: 100
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: SIA OmniScriptum Publishing; customerservice@vdm-vsg.de; ; Brivibas gatve 197; Riga; 1039; Lettland