Reversed Phase HPLC for a Validation and Determination of Udenafil (Zydena®) and Dapoxetine (Priligy®) Simultaneously in Tablet Dosage Form in Jordanian Market

Pharmacokinetic and pharmacodynamic features of dapoxetine, a novel drug for ‘on-demand’ treatment of premature ejaculation.

2. What should I know before I take PRILIGY?

The collected date was used (JBV) Jasso Berwyn Version 1.8, LC-Net- III/ADLC system. The column used was Thermo Hypersil type-3-BDS-C18 (200 mm × 4.6 mm, 5.0 μ) made in Germany. Optimization of High Performance Liquid Chromatography (HPLC)-Method The HPLC method was optimized by development a simultaneous analysis method for determination of Udenafil and dapoxetine HCl, simultaneously. For RP-HPLC, optimization the organic solvent Methanol (CH3OH) and pure water (H2O) was tested in ratio of 85: 15 but it found the result on the peak shape was not identical and correct due to the peak shape in this mixture is not good for the both of udenafil and dapoxetine. Hence pure water (H2O) was changed with a buffer solution (phosphate buffer).

How much to take

Organic solvent CH3OH: Phosphate (PO4) buffer pH 4.6 adjusted with ortho- phosphoric acid in the ratio of 85: 15 it was found the result of sharp peak was obtained for udenafil but, the result of dapoxetine HCl was hump shape peak obtained. After that the phosphate buffer was changed with tri-ethyl amine. Solvent Methanol 0.2% tri-ethyl amine in H2O pH adjusted to 4.5 with ortho-phosphoric acid in the ratio of 85: 15 was tested, the resulting sharp peak was observed for udenafil but slight tailing in peak was focused for HCl. In the Final of trails, CH3OH (Organic solvent of methanol) was changed to Acetonitrile (ACN) and the optimal mobile phase obtained was acetonitrile: 0.2% triethyl amine in water (H2O) at adjusted pH to 4.4 with ortho-phosphoric acid in the ratio 75: 25 V/V, with a flow rate 1.0 ml/min which provide an acceptable (tR) retention time), with high number of plates(N) and a better resolution (RS), more than another mobile phase tested before, for udenafil and dapoxetine HCl (Figure 3). Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. 16.Buvat J., Tesfaye F., Rothman M. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial.

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18.Pryor J.L., Althof S.E., Steidle C. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Editorial comment on: Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: the PASSION study. [DOI] [PMC free article] [PubMed] [Google Scholar] 22.Castiglione F., Albersen M., Hedlund P. Current pharmacological management of premature ejaculation: a systematic review and meta-analysis. Safety and efficacy of dapoxetine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study. 25.Mirone V., Arcaniolo D., Rivas D. Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the PAUSE study. Comparison of paroxetine and dapoxetine, a novel selective serotonin reuptake inhibitor in the treatment of premature ejaculation.

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[DOI] [PMC free article] [PubMed] [Google Scholar] 22.Castiglione F., Albersen M., Hedlund P. Current pharmacological management of premature ejaculation: a systematic review and meta-analysis. Safety and efficacy of dapoxetine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study. 25.Mirone V., Arcaniolo D., Rivas D.

Key Features:

Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the PAUSE study. Comparison of paroxetine and dapoxetine, a novel selective serotonin reuptake inhibitor in the treatment of premature ejaculation. [DOI] [PMC free article] [PubMed] [Google Scholar] 27.Jiann B.P., Huang Y.J. Assessing satisfaction in men with premature ejaculation after dapoxetine treatment in real-world practice. A prospective randomized controlled study to compare acupuncture and dapoxetine for the treatment of premature ejaculation. [DOI] [PMC free article] [PubMed] [Google Scholar] 27.Jiann B.P., Huang Y.J. Assessing satisfaction in men with premature ejaculation after dapoxetine treatment in real-world practice. A prospective randomized controlled study to compare acupuncture and dapoxetine for the treatment of premature ejaculation.

PCI DSS Compliant

In the present study a simultaneous determination of udenafil and dapoxetine HCL by RP-HPLC in pharmaceutical preparation found in Jordan Market as tablet dosage form. The proposed method is validated as per International Harmonization guidelines (ICH) [12,13]. Pure drug sample of Udenafil, Hikam Pharmaceuticals Group, Jordan, sample of B. Saudi Pharmaceutical Industries & Medical Appliances Corporation (SPIMACO) supply as a gift the dapoxetine HCl as pure drug sample of Batch No. Both was used without further purification because the assay certification shows that 99.91% (w/w) for udenafil and 98.99% (w/w) for dapoxetine HCl on dry phase.

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All chemicals or reagents which used in this study, were in term of HPLC grade and were purchased from Jordan and made by Merck Chemicals, Germany. Pregabalin was used as internal standard (IS) which obtained from Jordan Pharmaceutical Industries (JPM) B. 3584 as pure API powder, Figure 3 represent the structure formula of pregabalin. The High Pressure LC, system included a Pump (Model JW-asco PIU 3080), Intelligent-Sensitive Liquid Chromatography pump with auto-sampler programmed at 10-20 μl capacity per injection was applied in the system. The transducer (detector) which used of UV/Vis (JW-asco UV 3070) this model operated and fixed at a wavelength of 246 nm. 29.Verze P., Cai T., Magno C.

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Comparison of treatment emergent adverse events in men with premature ejaculation treated with dapoxetine and alternate oral treatments: results from a large multinational observational trial. Sign in to ask about medicines, check stock and place orders. 📦 How many units of do you want? 50) $event.target.value = 50" placeholder="Enter quantity" class="w-full px-4 !py-3 border-2 border-blue-300 rounded form-control text-gray-900 font-semibold" /> Your health buy priligy price made easy - just one click away Buy any product from our stores running 24hours. Research Article - Der Pharma Chemica ( 2018) Volume 10, Issue 4 Wael Abu Dayyih1*, Zainab Zakarya1, Alice Abu Dayyih2 and Israa Al-Ani3 1Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy –Faculty of Pharmacy and Medical Sciences/University of Petra-Jordan 2Department of Gynecology and Obstetrics, Faculty of Medicine/University of Saarland, Germany 3Department of Pharmacy, Faculty of Pharmacy and Medical Sciences/Al-Ahliyya Amman University-Jordan Wael Abu DayyihDepartment of Pharmaceutical Medicinal Chemistry and Pharmacognosy –Faculty of Pharmacy and Medical Sciences/University of Petra-Jordan A reversed phase high performance liquid chromatography was developed for estimation and determination of two actives pharmaceutical ingredient Udenafil (Zydena) and Dapoxetine (Priligy). In presence of pregabalin as internal standard. The chromatographic conditions were applied according to ICH-guidelines using Thermo Hypersil BDS–C18 (250 mm × 4.6 mm, 5.0 μ) the mobile phase containing acetonitrile: 0.2% triethyl amine in pure water (H2O) the adjusted pH was 4.4 using ortho- phosphoric acid (75: 25) with flow rate amount approximately 1 ml/min using UV detection at 246 nm. according to ICH-guidelines and statistical treatment of date the date for this method was linear with correlation coefficient R2 > 0.99 which prove that the method is convenient and applicable for the investigation and study of udenafil and dapoxetine HCl in drug formulation and commercials tablets found in Jordanian pharmaceutical market beyond any interference or interaction with the additives materials or the excipients. Udenafil (Zydena®), Dapoxetine HCl (Priligy®), Liquid Chromatography, Jordan Market, Validation Udenafil is a new drug for (ED) erectile dysfunction and chemically known 3- {1-CH3-7-oxo-3-propyl-1-H,4-H,7-H-pyrazolo- [4,3- d]- pyrimidin-5-yl}-N-[2-(1-methylpyrrolidin-2-yl)-ethyl]-4-propoxybenzene-1-sulfone-amide [1,2]. PDE-5 inhibitions are the first choice line in therapy of sexual ED [1-5]. Udenafil is a five new drug amongst the PDE-5 inhibitors group and fulfillment this needed for a many molecule having benefits of the existing agents with a good tolerably image [2]. Udenafil has been registered in Jordan market by JFDA under the trade name of Zydena tablet 100 and 200 mg also it has been registered in South Korea and some of European countries and India. Zydena has a molecular mass of 516.661 g/mol and solubility of 98e-02 g/l. Figure 1 represents structural formula of udenafil [1,2].

What is Premature Ejaculation

PDE-5 inhibitions are the first choice line in therapy of sexual ED [1-5]. Udenafil is a five new drug amongst the PDE-5 inhibitors group and fulfillment this needed for a many molecule having benefits of the existing agents with a good tolerably image [2]. Udenafil has been registered in Jordan market by JFDA under the trade name of Zydena tablet 100 and 200 mg also it has been registered in South Korea and some of European countries and India. Zydena has a molecular mass of 516.661 g/mol and solubility of 98e-02 g/l. Figure 1 represents structural formula of udenafil [1,2].

Outcome Measurements

Dapoxetine HCl, marketed as Priligy as trade priligy 90 mg name and chemically known a (1-S)-N, N-di-CH3-3-naphthalen-1- yloxy-1-phenyl-propan-1- amine HCl as seen in (Figure 2) is can be used for treatment of premature ejaculation in masculine humans [7]. Dapoxetine is a short acting Selective Serotonin Reuptake Inhibitor (SSRI). SSRI's are a group of components typically used as CNS medication exactly anti-depressants and their treatment of depression, anxiety and personality disorders, they can also by simulation of CNS, effective it can use in treating premature ejaculation problems, some cases of impotency in men and some cases hypnotics [7-9]. In previous studies shows that some methods reported for assay of udenafil and dapoxetine alone such as, quantification and stability indicating by reversed phase high pressure liquid chromatography/Rp-HPLC method for the determination of udenafil as active ingredient in in pharmaceutical preparation, some sensitive methods are recorded and some simple HPLC methods for validation of udenafil in human plasma or serum, more of stress degradation investigations on Udenafil and Estimation of stability- indicating LC analysis for drug formulation and pharmaceutical as dispensing dosage form and udenafil pharmacokinetics or dynamics in healthy volunteers, validation of a RP-HPLC assay for the determination of dapoxetine HCl in drug formulation, quantification of dapoxetine, an investigation parameters for treatment of CNS disorders as depression [8-10]. Many studies used term of Internal Standard (IS) which represent a chemical substance may be a drug which can be used for calibration curve by plotting the ratio of the target API signal to e internal standard signal as a function of the amount of the standards in the assay [8,11]. Dapoxetine HCl, marketed as Priligy as trade priligy 90 mg name and chemically known a (1-S)-N, N-di-CH3-3-naphthalen-1- yloxy-1-phenyl-propan-1- amine HCl as seen in (Figure 2) is can be used for treatment of premature ejaculation in masculine humans [7]. Dapoxetine is a short acting Selective Serotonin Reuptake Inhibitor (SSRI). SSRI's are a group of components typically used as CNS medication exactly anti-depressants and their treatment of depression, anxiety and personality disorders, they can also by simulation of CNS, effective it can use in treating premature ejaculation problems, some cases of impotency in men and some cases hypnotics [7-9]. In previous studies shows that some methods reported for assay of udenafil and dapoxetine alone such as, quantification and stability indicating by reversed phase high pressure liquid chromatography/Rp-HPLC method for the determination of udenafil as active ingredient in in pharmaceutical preparation, some sensitive methods are recorded and some simple HPLC methods for validation of udenafil in human plasma or serum, more of stress degradation investigations on Udenafil and Estimation of stability- indicating LC analysis for drug formulation and pharmaceutical as dispensing dosage form and udenafil pharmacokinetics or dynamics in healthy volunteers, validation of a RP-HPLC assay for the determination of dapoxetine HCl in drug formulation, quantification of dapoxetine, an investigation parameters for treatment of CNS disorders as depression [8-10]. Many studies used term of Internal Standard (IS) which represent a chemical substance may be a drug which can be used for calibration curve by plotting the ratio of the target API signal to e internal standard signal as a function of the amount of the standards in the assay [8,11].

• The 30 mg dosage is considered effective for most patients.
• Do not share your medication with others.
• Seek medical advice if you experience persistent side effects.
• Remember, psychological factors can also affect sexual performance.

In the present study a simultaneous determination of udenafil and dapoxetine HCL by RP-HPLC in pharmaceutical preparation found in Jordan Market as tablet dosage form.

Tip	Explanation
Take as prescribed	Do not exceed recommended dose
Avoid alcohol	Can worsen side effects
Report side effects	Especially severe headache or dizziness
Do not combine with other medications without consulting a doctor	To avoid interactions
Follow-up with doctor	For effectiveness and safety monitoring

The proposed method is validated as per International Harmonization guidelines (ICH) [12,13]. Pure drug sample of Udenafil, Hikam Pharmaceuticals Group, Jordan, sample of B.

• The 6-pack of Priligy 30 mg is portable and discreet.
• Do not crush or split the tablets unless directed.
• Always follow the prescribed dosage instructions.
• Keep out of reach of children and pets.

Saudi Pharmaceutical Industries & Medical Appliances Corporation (SPIMACO) supply as a gift the dapoxetine HCl as pure drug sample of Batch No. Both was used without further purification because the assay certification shows that 99.91% (w/w) for udenafil and 98.99% (w/w) for dapoxetine HCl on dry phase.

Product Description

29.Verze P., Cai T., Magno C. Comparison of treatment emergent adverse events in men with premature ejaculation treated with dapoxetine and alternate oral treatments: results from a large multinational observational trial. Sign in to ask about medicines, check stock and place orders. 📦 How many units of do you want? 50) $event.target.value = 50" placeholder="Enter quantity" class="w-full px-4 !py-3 border-2 border-blue-300 rounded form-control text-gray-900 font-semibold" /> Your health buy priligy price made easy - just one click away Buy any product from our stores running 24hours.

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Research Article - Der Pharma Chemica ( 2018) Volume 10, Issue 4 Wael Abu Dayyih1*, Zainab Zakarya1, Alice Abu Dayyih2 and Israa Al-Ani3 1Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy –Faculty of Pharmacy and Medical Sciences/University of Petra-Jordan 2Department of Gynecology and Obstetrics, Faculty of Medicine/University of Saarland, Germany 3Department of Pharmacy, Faculty of Pharmacy and Medical Sciences/Al-Ahliyya Amman University-Jordan Wael Abu DayyihDepartment of Pharmaceutical Medicinal Chemistry and Pharmacognosy –Faculty of Pharmacy and Medical Sciences/University of Petra-Jordan A reversed phase high performance liquid chromatography was developed for estimation and determination of two actives pharmaceutical ingredient Udenafil (Zydena) and Dapoxetine (Priligy). In presence of pregabalin as internal standard. The chromatographic conditions were applied according to ICH-guidelines using Thermo Hypersil BDS–C18 (250 mm × 4.6 mm, 5.0 μ) the mobile phase containing acetonitrile: 0.2% triethyl amine in pure water (H2O) the adjusted pH was 4.4 using ortho- phosphoric acid (75: 25) with flow rate amount approximately 1 ml/min using UV detection at 246 nm. according to ICH-guidelines and statistical treatment of date the date for this method was linear with correlation coefficient R2 > 0.99 which prove that the method is convenient and applicable for the investigation and study of udenafil and dapoxetine HCl in drug formulation and commercials tablets found in Jordanian pharmaceutical market beyond any interference or interaction with the additives materials or the excipients. Udenafil (Zydena®), Dapoxetine HCl (Priligy®), Liquid Chromatography, Jordan Market, Validation Udenafil is a new drug for (ED) erectile dysfunction and chemically known 3- {1-CH3-7-oxo-3-propyl-1-H,4-H,7-H-pyrazolo- [4,3- d]- pyrimidin-5-yl}-N-[2-(1-methylpyrrolidin-2-yl)-ethyl]-4-propoxybenzene-1-sulfone-amide [1,2]. All chemicals or reagents which used in this study, were in term of HPLC grade and were purchased from Jordan and made by Merck Chemicals, Germany. Pregabalin was used as internal standard (IS) which obtained from Jordan Pharmaceutical Industries (JPM) B. 3584 as pure API powder, Figure 3 represent the structure formula of pregabalin. The High Pressure LC, system included a Pump (Model JW-asco PIU 3080), Intelligent-Sensitive Liquid Chromatography pump with auto-sampler programmed at 10-20 μl capacity per injection was applied in the system.

• Priligy 30 mg is available by prescription only.
• The medicine should be taken orally with water.
• Common side effects include dizziness and nausea.
• Consult your doctor before starting Priligy.

The transducer (detector) which used of UV/Vis (JW-asco UV 3070) this model operated and fixed at a wavelength of 246 nm. The collected date was used (JBV) Jasso Berwyn Version 1.8, LC-Net- III/ADLC system. The column used was Thermo Hypersil type-3-BDS-C18 (200 mm × 4.6 mm, 5.0 μ) made in Germany. Optimization of High Performance Liquid Chromatography (HPLC)-Method The HPLC method was optimized by development a simultaneous analysis method for determination of Udenafil and dapoxetine HCl, simultaneously. For RP-HPLC, optimization the organic solvent Methanol (CH3OH) and pure water (H2O) was tested in ratio of 85: 15 but it found the result on the peak shape was not identical and correct due to the peak shape in this mixture is not good for the both of udenafil and dapoxetine.

Medication Class	Effect on Priligy	Notes
SSRIs	Increased risk of side effects	Use with caution, consult physician
CYP3A4 Inhibitors	Increased plasma levels	Adjust dose accordingly
Blood Thinners	Bleeding complications	Monitor for bleeding
Other PDE5 Inhibitors	Enhanced effects or side effects	Use under medical supervision
Alcohol	Increased sedation	Avoid alcohol for safety

Hence pure water (H2O) was changed with a buffer solution (phosphate buffer). Organic solvent CH3OH: Phosphate (PO4) buffer pH 4.6 adjusted with ortho- phosphoric acid in the ratio of 85: 15 it was found the result of sharp peak was obtained for udenafil but, the result of dapoxetine HCl was hump shape peak obtained. After that the phosphate buffer was changed with tri-ethyl amine.

Related Conditions

Pharmacokinetic and pharmacodynamic features of dapoxetine, a novel drug for ‘on-demand’ treatment of premature ejaculation. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. 16.Buvat J., Tesfaye F., Rothman M. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial.

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18.Pryor J.L., Althof S.E., Steidle C. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Editorial comment on: Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: the PASSION study. Solvent Methanol 0.2% tri-ethyl amine in H2O pH adjusted to 4.5 with ortho-phosphoric acid in the ratio of 85: 15 was tested, the resulting sharp peak was observed for udenafil but slight tailing in peak was focused for HCl. In the Final of trails, CH3OH (Organic solvent of methanol) was changed to Acetonitrile (ACN) and the optimal mobile phase obtained was acetonitrile: 0.2% triethyl amine in water (H2O) at adjusted pH to 4.4 with ortho-phosphoric acid in the ratio 75: 25 V/V, with a flow rate 1.0 ml/min which provide an acceptable (tR) retention time), with high number of plates(N) and a better resolution (RS), more than another mobile phase tested before, for udenafil and dapoxetine HCl (Figure 3).