Chiral Separation of (R,R)-Tadalafil and Its Enantiomer in Bulk Drug Samples and Pharmaceutical Dosage Forms by Chiral RP-LC

Madhavi, Alavala Siva; Reddy, G. S.; Suryanarayana, M.; Naidu, A.

doi:10.1365/s10337-008-0534-5

Cited by 6 publications

(3 citation statements)

References 19 publications

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“…A Novel RP-HPLC Method for the quantifi cation of Tadalafi l in formulations [ 12 ] . Chiral separation of ( r , r ) -Tadalafi l and its enantiomer in bulk drug samples and pharmaceutical dosage forms by chiral RP-LC [ 13 ] . The specifi c aim of the Introduction ▼ Tadalafi l is a potent and selective phosphodiesterase-5 (PDE-5) inhibitor, a secondary messenger for the smooth muscle relaxing eff ects of nitric oxide, which plays an important role in the vasodilation of erectile tissues [ 1 -3 ] .…”

Section: Validation and Methods Development Of Tadalafi L In Bulk And mentioning

confidence: 99%

Validation and Method Development of Tadalafil in Bulk and Tablet Dosage Form by RP-HPLC

et al. 2014

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A novel, precise, rapid and sensitive reverse phase high performance liquid chromatographic method has been developed for the validated estimation of Tadalafil in bulk and tablet dosage form. The separation was achieved on Agilent Eclipse XDB C18 column (150 mm×4.6 mm, 5 µ) using a mobile phase that consists of the buffer (potassium dihydrogen orthophosphate) and acetonitrile in the ration of 50:50 V/V, pH 6 was adjusted with orthophosphoric acid. The flow rate was maintained at 1.2 ml/min and the detection wavelength was 285 nm. The method was validated for linearity, specificity, sensitivity as per ICH guidelines. The retention time was found to be 3.181 for Tadalafil. The calibration curve was linear over the concentration range of 10-150 µg/ml. The % RSD was satisfactory which showed the method found to be reliable. The high percentage recovery confirmed the suitability of the method for estimation of Tadalafil in pharmaceutical dosage form. The developed method could be applicable for routine analysis of Tadalafil in bulk and tablet dosage form.

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Section: Validation and Methods Development Of Tadalafi L In Bulk And mentioning

confidence: 99%

Validation and Method Development of Tadalafil in Bulk and Tablet Dosage Form by RP-HPLC

et al. 2014

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“…Previous studies have shown that glycopeptide [52][53][54][55] and aromatic stationary phases [56,57] can be selective for closely related analytes in both HILIC and reversed phase modes. Mobile phase composition and pH are critical to optimizing their performance, and these features are described in Section 3 of the Supplementary Data.…”

Section: Effect Of the Mobile Phase On Separationmentioning

confidence: 99%

Separation of therapeutic peptides with cyclofructan and glycopeptide based columns in hydrophilic interaction liquid chromatography

Shu

Lang

Breitbach

et al. 2015

Journal of Chromatography A

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“…Likewise, vardenafil and tadalafil in different matrices were analyzed using different analytical systems, such as LC (Gratz et al, 2004;Ramakrishna et al, 2004;Madhavi et al, 2008;Farthing et al, 2010;Lake et al, 2010;Di et al, 2011;Lee et al, 2011;Hasegawa et al 2012), gas chromatography (Man et al, 2009;Papoutsis et al, 2010;Strano-Rossi et al, 2010) and capillary electrophoresis (Ali, Aboul-Enein et al, 2004;Flores et al, 2004;Idris;Alnajjar, 2007).…”

Section: Introductionmentioning

confidence: 99%

A review of analytical methods for the determination of four new phosphodiesterase type 5 inhibitors in biological samples and pharmaceutical preparations

Codevilla

Castilhos

Bergold

2013

Braz. J. Pharm. Sci.

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The introduction of oral phosphodiesterase type 5 inhibitor therapy in 1998 revolutionized the treatment of erectile dysfunction. Erectile dysfunction is the most common sexual problem in men. It often has a profound effect on intimate relationships and quality of life. The analysis of pharmaceuticals is an important part of the drug development process as well as for routine analysis and quality control of commercial formulations. Whereas the determination of sildenafil citrate, vardenafil and tadalafil are well documented by a variety of methods, there are few publications about the determination of udenafil, lodenafil carbonate, mirodenafil and avanafil. The paper presents a brief review of the action mechanism, adverse effects, pharmacokinetics and the most recent analytical methods that can determine drug concentration in biological matrices and pharmaceutical formulations of these four drugs. A introdução da terapia oral com inibidores da fosfodiesterase tipo 5, em 1998, revolucionou o tratamento da disfunção erétil. A disfunção erétil é o problema sexual mais comum em homens. Muitas vezes tem um efeito profundo nas relações íntimas e na qualidade de vida. A análise de produtos farmacêuticos é uma parte importante do processo de desenvolvimento de fármacos, bem como para a análise de rotina e controle de qualidade das formulações comerciais. Enquanto a determinação do citrato de sildenafila, vardenafila e tadalafila está bem documentada por uma variedade de métodos, existem poucas publicações sobre a determinação de udenafila, carbonato de lodenafila, mirodenafila e avanafila. O artigo apresenta uma breve revisão do mecanismo de ação, efeitos adversos, farmacocinética e os mais recentes métodos analíticos, que podem determinar a concentração do fármaco em matrizes biológicas e formulações farmacêuticas destes quatro fármacos.Unitermos: Inibidores da fosfodiesterase tipo 5/determinação/preparações farmacêuticas. Inibidores da fosfodiesterase tipo 5/determinação/matrizes biológicas Métodos analíticos. Disfunção erétil.

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Chiral Separation of (R,R)-Tadalafil and Its Enantiomer in Bulk Drug Samples and Pharmaceutical Dosage Forms by Chiral RP-LC

Cited by 6 publications

References 19 publications

Validation and Method Development of Tadalafil in Bulk and Tablet Dosage Form by RP-HPLC

Validation and Method Development of Tadalafil in Bulk and Tablet Dosage Form by RP-HPLC

Separation of therapeutic peptides with cyclofructan and glycopeptide based columns in hydrophilic interaction liquid chromatography

A review of analytical methods for the determination of four new phosphodiesterase type 5 inhibitors in biological samples and pharmaceutical preparations

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