Simultaneous Determination of Sildenafil, Tadalafil, and Vardenafil in Pharmaceutical Preparations by High-Temperature Gas Chromatography/Mass Spectrometry

Jeong, Yu-dong; Suh, SungIll; Kim, Jin Young; In, Moon Kyo; Paeng, Ki‐Jung

doi:10.1007/s10337-016-3185-y

Cited by 20 publications

(8 citation statements)

References 12 publications

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“…Several investigations have indicated that sildenafil has been illegally adulterated into some dietary supplements, herbal medicines and alcoholic drinks [4,5,6,7]. Limited by the complicated sample processing and extraction, traditional methods for determining sildenafil mainly focus on high-performance liquid chromatography (HPLC) [8,9], ultraviolet spectrophotometry (UV) [10,11], gas chromatography-mass spectrometry (GC-MS) [12,13], thin layer chromatography (TLC) [14,15] and near infrared spectrometry (NIR) [16,17]. Ramirez et al [18] quantified plasma levels of sildenafil and its metabolite by liquid chromatography (LC) with a C 18 reverse-phase column and UV detection; the limits of detection (LODs) and quantification were 1 and 10 ng/mL, respectively.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Sildenafil in Liquor and Health Wine Using Surface Enhanced Raman Spectroscopy

Xiao

2019

IJMS

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The illegal adulteration of sildenafil in herbal food supplements and alcoholic drinks immensely threatens human health due to its harmful side-effects. Therefore, it is important to accurately detect and identify the presence of sildenafil in alcoholic drinks. In this study, Opto Trace Raman 202 (OTR 202) was used as surface enhanced Raman spectroscopy (SERS) active colloids to detect sildenafil. The results demonstrated that the Raman enhancement factor (EF) of OTR 202 colloids reached 1.84 × 107 and the limits of detection (LODs) of sildenafil in health wine and liquor were found to be as low as 0.1 mg/L. Moreover, the SERS peaks of 645, 814, 1235, 1401, 1530 and 1584 cm−1 could be qualitatively determined as sildenafil characteristic peaks and the relationship between Raman peak intensity and sildenafil concentration in health wine and liquor were different. There was a good linear correlation between Raman peak intensity, and sildenafil concentration in health wine ranged 0.1–1 mg/L (0.9687< R2 < 0.9891) and 1–10 mg/L (0.9701 < R2 < 0.9840), and in liquor ranged 0.1–1 mg/L (0.9662 < R2 < 0.9944) and 1–20 mg/L (0.9625 < R2 < 0.9922). The relative standard deviations (RSD) were less than 5.90% (sildenafil in health wine) and 9.16% (sildenafil in liquor). The recovery ranged 88.92–104.42% (sildenafil in health wine) and 90.09–104.55% (sildenafil in liquor). In general, the sildenafil in health wine and liquor could be rapidly and quantitatively determined using SERS technique, which offered a simple and accurate alternative for the determination of sildenafil in alcoholic drinks.

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Section: Introductionmentioning

confidence: 99%

Analysis of Sildenafil in Liquor and Health Wine Using Surface Enhanced Raman Spectroscopy

Xiao

2019

IJMS

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“…Various analytical methods for the determination of either VAR or DAC in their pharmaceutical formulations and biological fluids have been reported. The reported analytical methods for determination of VAR include liquid chromatography [6][7][8][9][10][11], gas chromatography [12], atomic emission spectrometry [13], capillary electrophoresis [14], voltammetric methods [15][16][17] and different spectroscopic methods [18][19][20][21][22][23][24][25]. In addition, several methods were reported for quantitative determination of DAC either alone or simultaneously with the other newly approved drugs including different chromatographic methods [26][27][28][29], stability indicating HPLC studies in bulk and formulations [30][31][32][33], electrochemical methods [34][35][36], spectrofluorimetric methods [37][38][39] and thin layer chromatographic method [40].…”

Section: Introductionmentioning

confidence: 99%

Pencil Graphite Electrode Decorated with Xylenol Orange Flakes for Studying Possible Pharmacokinetic Interaction Between Vardenafil and Daclatasvir

et al. 2019

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The main aim of the current work is to investigate possible pharmacokinetic interactions between vardenafil hydrochloride (VAR), which is used for the treatment of erectile dysfunction and daclatasvir dihydrochloride (DAC), which is used for the treatment of chronic hepatitis C viral infection when they are concomitantly administered. Therefore, a sensitive and selective square‐wave voltammetric method was developed and validated for simultaneous determination of VAR and DAC using disposable pencil graphite electrode (PGE) modified with xylenol orange (X.O.) flakes as an electrochemical sensor. A full investigation of the experimental parameters for obtaining the highest electroanalytical signal with sufficient resolution between the oxidation peaks of two compounds was performed. It was found that VAR and DAC were resolved on X.O./PGE with different potentials at 1.4 V and 0.9 V, respectively using Britton‐Robinson buffer (pH 2.2) and 0.1 mol L−1 KCl as a supporting electrolyte. In addition, with the aid of cyclic voltammetry, a mechanistic scheme for the oxidation behaviour of both VAR and DAC was suggested. The proposed square wave voltammetric method was successfully applied for trace quantification of VAR and DAC in male rabbits. The suggested approach shows detection and quantification limits in rabbit plasma samples of 0.06 and 0.17 μmol L−1, respectively for VAR and 0.13 and 0.39 μmol L−1, respectively for DAC. The pharmacokinetic parameters of VAR alone and in combination with DAC after oral administration to rabbits were successfully estimated. The obtained results confirm that when DAC is co‐administered with VAR, plasma concentration of VAR increases, which necessitates dose adjustment for VAR to prevent toxicological consequences in patients.

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“…Therefore, the development of a sensitive and accurate analytical method for the simultaneous determination of PDE‐5 inhibitors is very crucial for screening of these drugs in complex matrices such as food and biological samples. There have been several reports in literature for the determination of different PDE‐5 inhibitors using HPLC , GC–MS or GC–MS/MS and LC–MS or LC–MS/MS . These methods have been used for the determinations of sildenafil, tadalafil and vardenafil in pharmaceuticals, biological samples such as hair, urine, plasma and breast milk, environmental samples (waste water and sewage sludge), beverage samples (energy drinks), herbal and dietary supplements.…”

Section: Introductionmentioning

confidence: 99%

“…These methods have been used for the determinations of sildenafil, tadalafil and vardenafil in pharmaceuticals, biological samples such as hair, urine, plasma and breast milk, environmental samples (waste water and sewage sludge), beverage samples (energy drinks), herbal and dietary supplements. LC–MS and LC–MS/MS methods are most common techniques among others for the analysis of ED drugs regarding to their high molecular weights and nonvolatile polar structures . Additionally, LC–QTOF‐MS/MS system is another alternative allowing us to perform accurate mass measurements of molecules and to facilitate the identification of compounds with high assurance even in complex matrices .…”

Section: Introductionmentioning

confidence: 99%

Accurate and sensitive determination of sildenafil, tadalafil, vardenafil, and avanafil in illicit erectile dysfunction medications and human urine by LC with quadrupole‐TOF‐MS/MS and their behaviors in simulated gastric conditions

Özbek

Bakırdere

2018

J of Separation Science

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The widespread use of phosphodiesterase‐5 inhibitors has attracted broad attention of counterfeiters to develop illicit erectile products with inaccurate amounts, unknown toxicity, and purity of active ingredients. Correspondingly, intake of these products endangers consumer health and needs to be screened for precautionary actions to reduce this risk. Therefore, in this study, a sensitive and rapid analytical method has been developed for simultaneous determination of selected phosphodiesterase‐5 inhibitors present in illicit erectile medications and human urine. Quantification of the analytes was performed by liquid chromatography coupled with quadrupole‐time‐of‐flight tandem mass spectrometry system. The chromatographic separation was successfully achieved with a run period of 8 min. Low detection limits were obtained in the range of 1.63–9.81 ng/g with relative standard deviations below 7.72% obtained using the replicate measurements of lowest concentration in calibration plots. The analytical performance of the proposed method proved good linearity, low detection limits, good accuracy and precision with high percent recoveries for human urine samples. Developed method was successfully applied to real samples including four different brands of illicit erectile medications. The results obtained revealed the presence of high levels of sildenafil in analyzed samples. The behaviors of selected phosphodiesterase‐5 inhibitors were also studied in simulated gastric conditions.

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Simultaneous Determination of Sildenafil, Tadalafil, and Vardenafil in Pharmaceutical Preparations by High-Temperature Gas Chromatography/Mass Spectrometry

Cited by 20 publications

References 12 publications

Analysis of Sildenafil in Liquor and Health Wine Using Surface Enhanced Raman Spectroscopy

Analysis of Sildenafil in Liquor and Health Wine Using Surface Enhanced Raman Spectroscopy

Pencil Graphite Electrode Decorated with Xylenol Orange Flakes for Studying Possible Pharmacokinetic Interaction Between Vardenafil and Daclatasvir

Accurate and sensitive determination of sildenafil, tadalafil, vardenafil, and avanafil in illicit erectile dysfunction medications and human urine by LC with quadrupole‐TOF‐MS/MS and their behaviors in simulated gastric conditions

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