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A Validated TLC-Densitometric Method for the Determination of Mesterolone in Bulk Material and in Tablets
Joint Authors
Dołowy, Małgorzata
Filip, Katarzyna
Zagrodzka, Joanna
Pyka, Alina
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-12-31
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Mesterolone is a synthetic androgenic steroid indicating a weak anabolic activity.
A new, simple in use, and economical TLC-densitometric method in normal phase system (NP-TLC) has been developed and validated for the identification and quantitative determination of mesterolone in bulk drug and in tablet formulation.
NP-TLC analysis was performed on aluminium plates precoated with silica gel 60F254 as the stationary phase using chloroform-acetone (40 : 10, v/v) as mobile phase.
Densitometric analysis was carried out at λ = 745 nm after staining with phosphomolybdic acid.
These conditions were found to give visible (dark blue) spot and sharp peak, respectively, for mesterolone at R F 0.75 ± 0.02 and enabled satisfactory separation of mesterolone from its related substance (potential impurity).
The proposed NP-TLC-densitometric method was validated for specificity, linearity, precision, accuracy, robustness, and sensitivity according to ICH guideline and other validation requirements.
The limit of detection (LOD) and limit of quantification (LOQ) were 61.0 ng·spot−1 and 184.0 ng·spot−1, respectively.
The percent content of mesterolone in marketed tablet formulation was found to be 99.40% of label claim.
The developed TLC-densitometric method can be successfully used in quality control of mesterolone in bulk material and also tablet formulation.
American Psychological Association (APA)
Dołowy, Małgorzata& Pyka, Alina& Filip, Katarzyna& Zagrodzka, Joanna. 2015. A Validated TLC-Densitometric Method for the Determination of Mesterolone in Bulk Material and in Tablets. BioMed Research International،Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1054676
Modern Language Association (MLA)
Dołowy, Małgorzata…[et al.]. A Validated TLC-Densitometric Method for the Determination of Mesterolone in Bulk Material and in Tablets. BioMed Research International No. 2015 (2015), pp.1-8.
https://search.emarefa.net/detail/BIM-1054676
American Medical Association (AMA)
Dołowy, Małgorzata& Pyka, Alina& Filip, Katarzyna& Zagrodzka, Joanna. A Validated TLC-Densitometric Method for the Determination of Mesterolone in Bulk Material and in Tablets. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-8.
https://search.emarefa.net/detail/BIM-1054676
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1054676