Simultaneous Determination of Tadalafil and Its Related Compounds in Pharmaceutical Dosage Forms by Uplc

Satheesh, B.; Ganesh, K. K. Sree; Saravanan, D.

doi:10.1080/10826076.2012.692143

Cited by 12 publications

(3 citation statements)

References 10 publications

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“…The LOQ detected in the present study was lower than those reported in the previous HPLC-FL methods (Niebch et al, 1992;Narang et al, 1984). In contrast, methods carried out with expensive devices such as LC MS-MS with Atmospheric Pressure Chemical Ionization (APCI) (Chen et al, 2001), Electrospray Ionization (ESI) (Zhong et al, 2001;Kandasamy et al, 2011) and Ultra-Performance Liquid Chromatography (UPLC) (Satheesh et al, 2012) showed comparable values of selectivity, accuracy, precision, stability and specificity to those found in this study. The findings concerning short and long term stability indicated that the room temperature and storage of analyte in plasma samples at −20° C is adequate and no stability-related problems would be expected during routine analyses for pharmacokinetic study.…”

Section: Discussioncontrasting

confidence: 51%

Bioanalytical Method Validation and Quantification of Flupirtine in Canine Plasma by HPLC with Spectrofluorimetric Detection

Vito¹,

Owen²,

Giorgi³

2015

American Journal of Animal and Veterinary Sciences

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Flupirtine (FLU) is a non-opioid analgesic drug belongs to the class of N-Methyl-D-Aspartate (NMDA) antagonist without antipyretic or antiphlogistic properties. No analytical method to detect FLU in canine plasma samples through a fluorimetric detector has been published to date. The analytical method described in this work provides a selective and accurate quantification of FLU. The mobile phase consisted of ACN:AcONH4 (20 mM) pH 6.8 (60:40, v/v) at a flow rate of 1 mL min−1 in isocratic mode. Excitation and emission wavelengths were set at 323 and 370 nm, respectively. The recoveries of FLU and IS (trazodone) were about 89 and 77%. Typical retention times for FLU and IS was 4.6±0.2 and 5.8±0.2 min, respectively. Limits of quantification and detection were 1 and 0.3 ng/mL, respectively. The described method was validated according to international guidelines on the bioanalytical method validation. The applicability of this method was verified by determining FLU in canine plasma after single oral treatment with 5 mg kg−1 of Efiret®. The low LOQ showed that the present method could be useful for the FLU measurement even when administered in sub-clinical doses

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Section: Discussioncontrasting

confidence: 51%

Bioanalytical Method Validation and Quantification of Flupirtine in Canine Plasma by HPLC with Spectrofluorimetric Detection

Vito¹,

Owen²,

Giorgi³

2015

American Journal of Animal and Veterinary Sciences

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“…Tadalafil relaxes the neck muscle of the bladder to relieve benign prostatic hyperplasia symptoms [ 19 ] and is chemically known as [pyrazino‐[1′,2′:1,6]pyrido[3,4‐b] indole‐1,4‐dione,6(1,3‐benzodioxol‐5‐yl)2,3,6,7,12,12a‐hexahydro‐2‐methyl‐,(6R,12aR)] [ 20,21 ] (Figure 2). Various chromatographic, [ 22–28 ] spectrophotometric, [ 29–35 ] voltammetric [ 36 ] and spectrofluorimetric analytical methods have been applied for tadalafil determination. [ 37,38 ]…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of citalopram and tadalafil by the second derivative synchronous fluorescence method in biological fluids; application of Box–Behnken optimization design

et al. 2020

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This is the first study focusing solely on that determination of tadalafil in the presence of citalopram as an antidepressant drug. The determination in biological fluids of a co‐administered antidepressant drug and a sexual stimulation drug is a very critical and important step for psychotic and ischaemic heart disease patients, especially in cases of emergency and this requires therapeutic drug monitoring. A sensitive, efficient and rapid assay was selected satisfactorily and applied for simultaneous determination of citalopram and tadalafil either in their pure forms, in tablet dosage forms or in spiked human plasma. There was a large overlap for both drugs, forming the broad band found in conventional fluorescence spectra and their related synchronous fluorescence intensity. Therefore, the development of a highly sensitive second derivative synchronous fluorescence method was demonstrated that removed this overlap. The proposed method depended on measuring the amplitudes of the second derivative of synchronous fluorescence intensity at suitable wavelengths of 301 nm and 367 nm for citalopram and tadalafil at Δλ = 60 nm, respectively. Box–Behnken design as a response surface methodology was used to fit models and create an optimization process encompassing a set of factors and resulting in an optimum response value specifically designed for this method. Under optimum conditions, the linear dynamic ranges for citalopram and tadalafil estimation were 20–900 and 5–400 ng ml−1 with detection limits of 5.40 and 1.43 ng ml−1, respectively.

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“…A UPLC method for the assay of FLU in dosage form in the presence of its related substances was reported [10], but the method did not satisfy the regulatory requirements and did not study the degradation profile, nor characterize the degradation products under stress conditions. Up to date, the literature review did not reveal any study on a stability-indicating HPLC method or/and the identification and characterization of degradation products for FLU in dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Identification of Degradation Products and Stability-Indicating RP-HPLC Method for Determination of Flupirtine Maleate in Pharmaceutical Dosage Forms

Peraman¹,

Lalitha²,

Raja³

et al. 2014

Sci. Pharm.

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In this stability-indicating, reversed-phase high-performance liquid chromatographic method for flupiritine maleate, forced degradation has been employed and the formed degradants were separated on a C18 column with a 80:20% v/v mixture of methanol-water containing 0.2% (v/v) triethylamine; the pH was adjusted to 3.1. The flow rate was 1 mLmin−1 and the photodiode array detection wavelength was 254 nm. Forced degradation of the drug was carried out under acidic, basic, thermal, photolytic, peroxide, and neutral conditions. Chromatographic peak purity data indicated no co-eluting peaks with the main peaks. This method resulted in the detection of seven degradation products (D1–D7). Among these, three major degradation products from acidic and basic hydrolysis were identified and characterized by 1H-NMR, 13C-NMR, and mass spectral data. The method was validated as per International Conference on Harmonization guidelines (Q2). The linearity of the method was in the concentration range of 20–120 μgmL−1. The relative standard deviations for intra- and interday precision were below 1.5%. The specificity of the method is suitable for the stability-indicating assay.

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Simultaneous Determination of Tadalafil and Its Related Compounds in Pharmaceutical Dosage Forms by Uplc

Cited by 12 publications

References 10 publications

Bioanalytical Method Validation and Quantification of Flupirtine in Canine Plasma by HPLC with Spectrofluorimetric Detection

Bioanalytical Method Validation and Quantification of Flupirtine in Canine Plasma by HPLC with Spectrofluorimetric Detection

Simultaneous determination of citalopram and tadalafil by the second derivative synchronous fluorescence method in biological fluids; application of Box–Behnken optimization design

Identification of Degradation Products and Stability-Indicating RP-HPLC Method for Determination of Flupirtine Maleate in Pharmaceutical Dosage Forms

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