Quantitative determination of Dapoxetine Hydrochloride and Tadalafil using different validated spectrophotometric methods

Magdy, Maimana A.; Anwar, Basma H; Naguib, Ibrahim A.; Abdelhamid, Nessreen S.

doi:10.1016/j.saa.2019.117611

Cited by 28 publications

(15 citation statements)

References 14 publications

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“…On reviewing literature, TMS was quantified by several methods, namely; TLC [16][17][18], HPLC in different matrices [18][19][20][21], capillary electrophoresis [16], spectrophotometry [16,[22][23][24], and electrochemical methods [16,25]. For TAD, several methods were reported for its determination includ-ing TLC [26][27][28][29], HPLC [26,[30][31][32][33][34][35][36], gas chromatography [26,37], capillary electrophoresis [26], spectrophotometry [26,[38][39][40][41], and electrochemical methods [42][43][44].…”

Section: Introductionmentioning

confidence: 99%

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

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

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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.

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Section: Introductionmentioning

confidence: 99%

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

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

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“…The published analytical methods for DPX involve spectrophotometric, [ 3–7 ] and spectrofluorimetric approaches based on native fluorescence properties, [ 8 ] synchronous spectrofluorimetry, [ 9 ] or association complex with mercurochrome, [ 10 ] HPTLC, [ 11 ] high‐performance liquid chromatography (HPLC) using ultraviolet (UV) or fluorescence detectors [ 12–14 ] , and electrochemical methods. [ 15,16 ]…”

Section: Introductionmentioning

confidence: 99%

“…Most of the published papers for DPX assay use spectrophotometric techniques that suffer from low sensitivity, are strongly influenced by combined excipient especially UV method, and comprise extraction steps that render the procedure strenuous and lengthy. [ 3–7 ] Other techniques involve sophisticated HPLC instrumentation that needs high pure grade organic solvents, multiple steps in sample pretreatment, high cost detectors, and individuals with an excellent expertise in instrument usage, plus periodic maintenance and part changing is necessary. Few fluorimetric approaches depend on native fluorescence properties or formation of a binary complex with mercurochrome and, to date, no resonance Rayleigh scattering (RRS) has been performed.…”

Section: Introductionmentioning

confidence: 99%

Investigation of the association complex formed between dapoxetine and erythrosine‐B for facile dapoxetine assay in pharmaceutical formulation using resonance Rayleigh scattering and spectrofluorimetric techniques

2021

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Premature ejaculation is a male sexual problem that is marked by rapid ejaculation and quick attainment of orgasm. Dapoxetine belongs to the antidepressant category and modulates its action by preventing the reuptake of serotonin by neurons. Dapoxetine is marketed as an off‐label therapy for premature ejaculation. Here, two facile, sensitive, and green compatible approaches were established for dapoxetine assay. The approaches chemically rely on association complex formed between erythrosine‐B and dapoxetine in an acidic buffered medium. The quenching effect of the formed complex on the native erythrosine fluorescence at emission 553.5 nm is simply the main idea of spectrofluorimetric assay, while resonance Rayleigh scattering methodology uses augmentation of resonance Rayleigh scattering spectrum at 345 nm by the added dapoxetine. The current approaches exhibit linearity between response and dapoxetine concentration over 0.2–2.5 μg/ml and 0.3–3.0 μg/ml for spectrofluorimetric and resonance Rayleigh scattering (RRS) methods, respectively. All variables affecting methods and complex formation were studied and precisely optimized. The criteria of validation were performed by the directives provided by International Conference on Harmonization's (ICH) Guidelines and limits of detection were 0.06 and 0.05 μg/ml for spectrofluorimetric and RRS techniques, respectively. Finally, the approaches were applied with acceptable results for pharmaceutical formulation analysis.

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“…1b), promotes the obstruction of the serotonin transporter, leading to the enhancement of the effect of serotonin at the postsynaptic cle, thus, promoting the ejaculatory delay. 2 Combining both drugs in a single dosage form for the treatment of erectile dysfunction was officially approved by the U.S. Food and Drug Administration (FDA) in April 2012. 3 A literature survey revealed some analytical techniques for Avanal and Dapoxetine determination either individually or in conjunction with other medicines.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of Avanafil and Dapoxetine in human plasma using liquid chromatography/tandem mass spectrometry (LC-MS/MS) based on a protein precipitation technique

et al. 2021

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Quantitative determination of Dapoxetine Hydrochloride and Tadalafil using different validated spectrophotometric methods

Cited by 28 publications

References 14 publications

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

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

Investigation of the association complex formed between dapoxetine and erythrosine‐B for facile dapoxetine assay in pharmaceutical formulation using resonance Rayleigh scattering and spectrofluorimetric techniques

Simultaneous determination of Avanafil and Dapoxetine in human plasma using liquid chromatography/tandem mass spectrometry (LC-MS/MS) based on a protein precipitation technique

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