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Determination of Melphalan by Micelle Enhanced Spectrofluorimetric Method: Application to Content Uniformity Testing and Human Plasma

Bestimmung von Melphalan mithilfe einer durch Mizellen verstärkten spektrofluorimetrischen Methode: Methodenanwendung zum Test der Homogenität des Wirkstoffes (Content Uniformity Testing) und im menschlichem Blut
Naga Gayatri Sambhani and Valsala Madhavan Nair Biju

Abstract

This manuscript describes a responsive, rapid, validated and economical spectrofluorimetric method for determination of Melphalan in its pharmaceutical dosage forms and spiked human plasma. The proposed method is relied on the investigation of fluorescence action of Melphalan in Tween-80 micellar system. The Melphalan shows strong native fluorescence at λem 365 nm upon excitation at λex 265 nm in Tween-80 system. There was good enhancement (1.68 fold) in fluorescence intensity in the presence of Tween-80. The proposed approach has a good linearity in the concentration range of 0.2 μg/mL–2 μg/mL. The lower limit of detection and that of quantitation was 0.03 μg/mL and 0.08 μg/mL respectively. The developed method has been validated and applied for content uniformity testing of Melphalan medicines available on the market and Melphalan spiked human plasma samples. The results are statistically compared and were found to be in good agreement to those obtained by comparison methods.

Kurzfassung

Dieses Manuskript beschreibt eine reaktionsschnelle, validierte und kostengünstige spektrofluorimetrische Methode zur Bestimmung von Melphalan in seinen pharmazeutischen Darreichungsformen und in mit Melphalan aufgestocktem Humanplasma. Die vorgeschlagene Methode beruht auf der Bestimmung der Fluoreszenzwirkung von Melphalan im Tween-80-Mizellensystem. Das Melphalan zeigt im Tween-80-System eine starke Eigenfluoreszenz bei λem 365 nm und nach Anregung eine Fluoreszenz bei λex 265 nm. In Gegenwart von Tween-80 war die Fluoreszenzintensität um das 1,68-fache erhöht. Der vorgeschlagene Ansatz zeigt eine gute Linearität im Konzentrationsbereich von 0,2 μg/ml–2 μg/mL. Die untere Nachweis- und Bestimmungsgrenze betrug 0,03 μg/ml bzw. 0,08 ug/ml. Die entwickelte Methode ist validiert und wird für die Prüfung der Homogenität von Melphalan enthaltenen Arzneimitteln und in mit Melphalan aufgestockten Humanplasmaproben angewendet. Die Ergebnisse wurden statistisch verglichen und stimmten gut mit denen überein, die durch Vergleichsmethoden erhalten wurden.


Correspondence address, Dr. Valsala Madhavan Nair Biju, Associate Professor, Department of Chemistry, National Institute of Technology, Tiruchirappalli, Tamil Nadu 620015, Tel.: +91 0431-2503638, E-Mail: ,

Dr. Valsala Madhavan Nair Biju, PhD: Associate Professor of Analytical Chemistry in the National Institute of Technology, Tiruchirappalli, Tamil Nadu, India. His research area interest includes Pharmaceutical Analysis, Electro Chemical Sensors, Optical Sensors and Ionic liquids.

Naga Gayatri Sambhani is the full time Research Scholar. Working under the supervision of Dr. Valsala Madhavan Nair Biju.


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Received: 2018-09-13
Accepted: 2019-03-22
Published Online: 2020-01-23
Published in Print: 2020-01-21

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