STABILITY INDICATING SPECTROFLUORIMETRIC QUANTIFICATION OF TAPENTADOL HCL AND APPLICATION TO IN-VITRO DISSOLUTION STUDIES
Panikumar.D.Anumolu*, Haripriya A, Sirisha N, ...
Department of Pharmaceutical Analysis, Gokaraju Rangaraju College of Pharmacy, Osmania University, Hyderabad, Andhra Pradesh-500090 India
Keywords: Emission Wavelength – 592 nm, Excitation Wavelength – 272 nm, Fluorimetry, Forced degradation, tapentadol HC
Abstract

Purpose: In this present work a simple, rapid, specific and highly sensitive spectrofluorimetric method was developed and validated for the quantification of tapentadol HCl bulk drug and pharmaceutical dosage forms and proposed method was also applied to study of forced degradation and in-vitro dissolution studies. Materials and Methods: The fluorescence intensity of tapentadol HCl in distilled water was measured at emission wavelength 592 nm after excitation at 272 nm by using a Shimadzu (Japan) RF-5301 PC spectrofluorophotometer. A linear relationship was found between fluorescence intensity and concentration in the range of 1-6 µg/mL with a good correlation coefficient – 0.999. Results: The detection and quantification limits were found to be 23.01 and 76.72 ng/mL, respectively. The proposed method was applied for quantification of tapentadol HCl in tablets, with percentage recovery of 99.95–101.45% and percentage RSD values were found to be less than 2 for accuracy and precision studies. Statistical analysis of the results revealed high accuracy and good precision. Conclusion: The suggested procedures could be used for the determination of tapentadol HCl in drug substance and drug products as well as in presence of its degradation products.

Article Information

Identifiers and Pagination:
Year:2013
Volume:5
First Page:89
Last Page:99
Publisher Id:JAppPharm (2013 ). 5. 89-99
Article History:
Received:May 14, 2013
Accepted:June 21, 2013
Collection year:2013
First Published:July 1, 2013


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Editor in Chief
Prof. Dr. Cornelia M. Keck (Philipps-Universität Marburg)
Marburg, Germany

Bibliography

Welcome to the research group of Prof. Dr. Cornelia M. Keck in Marburg. Cornelia M. Keck is a pharmacist and obtained her PhD in 2006 from the Freie Universität (FU) in Berlin. In 2009 she was appointed as Adjunct Professor for Pharmaceutical and Nutritional Nanotechnology at the University Putra Malaysia (UPM) and in 2011 she obtained her Venia legendi (Habilitation) at the Freie Universität Berlin and was appointed as a Professor for Pharmacology and Pharmaceutics at the University of Applied Sciences Kaiserslautern. Since 2016 she is Professor of Pharmaceutics and Biopharmaceutics at the Philipps-Universität Marburg. Her field of research is the development and characterization of innovative nanocarriers for improved delivery of poorly soluble actives for healthcare and cosmetics. Prof. Keck is executive board member of the German Association of Nanotechnology (Deutscher Verband Nanotechnologie), Vize-chairman of the unit „Dermocosmetics“ at the German Society of Dermopharmacy, active member in many pharmaceutical societies and member of the BfR Committee for Cosmetics at the Federal Institute for Risk Assessment (BfR).

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