Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

The advent of a new pharmaceutical formulation evokes the need for examining the chemical stability of their constituents and establishing proper stability‐indicating methods. Herein, the stability of the newly co‐formulated Tamsulosin and Tadalafil were examined under different stress conditions. T...

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Bibliographic Details
Published in:Journal of separation science 2021-01, Vol.44 (2), p.530-538
Main Authors: Rezk, Mamdouh R., Abdel‐Moety, Ezzat M., Wadie, Mina, Tantawy, Mahmoud A.
Format: Article
Language:English
Subjects:
Acetonitrile
Ammonia
Chromatography
Degradation
Densitometers
Drugs
Ethyl acetate
Flow velocity
Fractionation
High performance liquid chromatography
Ions
Linearity
liquid chromatography
Silica gel
Silicon dioxide
stability
Stability analysis
tadalafil
tamsulosin
Toluene
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Summary:The advent of a new pharmaceutical formulation evokes the need for examining the chemical stability of their constituents and establishing proper stability‐indicating methods. Herein, the stability of the newly co‐formulated Tamsulosin and Tadalafil were examined under different stress conditions. The acidic degradation of Tamsulosin yielded its sulfonated derivative, while Tadalafil was susceptible to both acidic and basic degradation. Two stability‐indicating chromatographic methods, namely; high‐performance thin‐layer chromatography and high‐performance liquid chromatography, have been developed. Significant high‐performance thin‐layer chromatography‐fractionation could be achieved by utilizing a stationary phase of silica gel 60 F254 and a mobile phase composed of ethyl acetate/toluene/methanol/ammonia (4:2:4:0.6, by volumes) with densitometric recording at 280 nm over a concentration range of 0.5–25 μg/band for both drugs. The HPLC‐separation could be reached on XBridge® C18 column isocraticaly by using a mobile phase having acetonitrile/phosphate buffer, pH 6.0 (45:55, v/v) pumped at a flow rate of 1.7 mL/min and applying diode array ultraviolet‐detection at 210 nm over a linearity range of 3–70 μg/mL for each drug. Specificity of the two methods was additionally assured via peak purity assessment. Moreover, the methods were distinctly exploited for evaluating the drugs’ stability in accelerated stability‐studied samples of Tamplus® capsules.
ISSN:1615-9306
1615-9314
DOI:10.1002/jssc.202000975