Stability assessment of tamsulosin and tadalafil co-formulated in capsules by two validated chromatographic methods
| Autor: | Ezzat M. Abdel-Moety, Mina Wadie, Mamdouh R. Rezk, Mahmoud A. Tantawy |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Tamsulosin
Drug Compounding Ethyl acetate Filtration and Separation Capsules 02 engineering and technology Derivative Pharmaceutical formulation 01 natural sciences Analytical Chemistry Tadalafil chemistry.chemical_compound Drug Stability Acetonitrile Chromatography High Pressure Liquid Chromatography Silica gel 010401 analytical chemistry 021001 nanoscience & nanotechnology Toluene 0104 chemical sciences chemistry Chemical stability Methanol Chromatography Thin Layer 0210 nano-technology |
| Zdroj: | Journal of separation scienceREFERENCES. 44(2) |
| ISSN: | 1615-9314 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text