Chromatographic analysis of some drugs employed in erectile dysfunction therapy: Qualitative and quantitative studies using calixarene stationary phase

In this study, the effect of change in chromatographic process variables on the retention behavior of four drugs employed in erectile dysfunction therapy on a calixarene stationary phase is described. Three of these drugs are known to treat erectile dysfunction, namely, sildenafil citrate, tadalafil...

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Veröffentlicht in:Journal of separation science 2014-10, Vol.37 (20), p.2814-2824
Hauptverfasser: Hashem, Hisham, Ibrahim, Adel Ehab, Elhenawee, Magda
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Ibrahim, Adel Ehab
Elhenawee, Magda
description In this study, the effect of change in chromatographic process variables on the retention behavior of four drugs employed in erectile dysfunction therapy on a calixarene stationary phase is described. Three of these drugs are known to treat erectile dysfunction, namely, sildenafil citrate, tadalafil, and apomorphine hydrochloride, and one drug that is used as opioid analgesic, tramadol hydrochloride, which is quiet widely misused to treat premature ejaculation. The results indicate the importance of considering the structure and pKa values of drugs to be separated along with mobile phase composition. A new optimized, rapid, and accurate liquid chromatography method is also established for simultaneous determination of sildenafil citrate, tadalafil, and apomorphine hydrochloride in pharmaceutical preparations and bulk powders. The chromatographic separation of the three pharmaceuticals was achieved on a calixarene column in less than 10 min using a binary mobile phase of 35% acetonitrile and 65% 50 mM sodium perchlorate pH2.5 at 1 mL/min flow rate. The method was validated for system efficiency, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability, and robustness. Statistical analysis proved that the method enabled reproducible and selective quantification of all three analytes in bulk drugs and in pharmaceutical preparations.
doi_str_mv 10.1002/jssc.201400276
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Sep. Science</addtitle><description>In this study, the effect of change in chromatographic process variables on the retention behavior of four drugs employed in erectile dysfunction therapy on a calixarene stationary phase is described. Three of these drugs are known to treat erectile dysfunction, namely, sildenafil citrate, tadalafil, and apomorphine hydrochloride, and one drug that is used as opioid analgesic, tramadol hydrochloride, which is quiet widely misused to treat premature ejaculation. The results indicate the importance of considering the structure and pKa values of drugs to be separated along with mobile phase composition. A new optimized, rapid, and accurate liquid chromatography method is also established for simultaneous determination of sildenafil citrate, tadalafil, and apomorphine hydrochloride in pharmaceutical preparations and bulk powders. The chromatographic separation of the three pharmaceuticals was achieved on a calixarene column in less than 10 min using a binary mobile phase of 35% acetonitrile and 65% 50 mM sodium perchlorate pH2.5 at 1 mL/min flow rate. The method was validated for system efficiency, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability, and robustness. 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A new optimized, rapid, and accurate liquid chromatography method is also established for simultaneous determination of sildenafil citrate, tadalafil, and apomorphine hydrochloride in pharmaceutical preparations and bulk powders. The chromatographic separation of the three pharmaceuticals was achieved on a calixarene column in less than 10 min using a binary mobile phase of 35% acetonitrile and 65% 50 mM sodium perchlorate pH2.5 at 1 mL/min flow rate. The method was validated for system efficiency, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability, and robustness. Statistical analysis proved that the method enabled reproducible and selective quantification of all three analytes in bulk drugs and in pharmaceutical preparations.</abstract><cop>Weinheim</cop><pub>Blackwell Publishing Ltd</pub><pmid>25175553</pmid><doi>10.1002/jssc.201400276</doi><tpages>11</tpages></addata></record>
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subjects Analysis
Apomorphine - analysis
Apomorphine - therapeutic use
Biological and medical sciences
Buffers
Calixarene column
Calixarenes
Calixarenes - chemistry
Carbolines - analysis
Carbolines - therapeutic use
Chromatographic variables
Chromatography
Chromatography, High Pressure Liquid - methods
Citrates
Drugs
Erectile dysfunction
Erectile Dysfunction - drug therapy
General pharmacology
High-performance liquid chromatography
Humans
Hydrochlorides
Hydrogen-Ion Concentration
Limit of Detection
Male
Medical sciences
Pharmaceutical Preparations - chemistry
Pharmaceuticals
Pharmacology
Pharmacology. Drug treatments
Piperazines - analysis
Piperazines - therapeutic use
Purines - analysis
Purines - therapeutic use
Reproducibility of Results
Sexual disorders
Sildenafil Citrate
Sulfonamides - analysis
Sulfonamides - therapeutic use
Tadalafil
Therapy
title Chromatographic analysis of some drugs employed in erectile dysfunction therapy: Qualitative and quantitative studies using calixarene stationary phase
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