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Objective:To establish an HPLC method for the determination of flibanserin and its related substances. Methods: A Phenomenex Luna C18 column(150 mm × 4. 60 mm, 5 μm) was used, the mobile phase consisted of 0. 02 mol·L-1 potassium di-hydrogen phosphate solution (pH was adjusted to 6. 0 by sodium hydroxide)-methanol and acetonitrile (4 :1), the flow rate was 1. 0 ml·min-1 , the column temperature was 30℃, the detection wavelength was 260 nm, and the injection volume was 10 μl. Results:Flibanserin and all the related compounds could be well separated. The linear range was 20-500 μg·ml-1(r=0. 9998), the average recovery was 100. 0%(RSD=0. 90%,n=9). The content of the main component in 4 batches of samples was 99. 6%, 99. 8%, 100. 4% and 99. 4%, respectively. The single impurity limit was set at 0. 1% and the limit of total impurities was set at 0. 5%. Con-clusion:The method is specific and accurate, which can be applied in the determination of content and related substances of fliban-serin.
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Objective:To establish an HPLC method for the determination of flibanserin and its related substances. Methods: A Phenomenex Luna C18 column(150 mm × 4. 60 mm, 5 μm) was used, the mobile phase consisted of 0. 02 mol·L-1 potassium di-hydrogen phosphate solution (pH was adjusted to 6. 0 by sodium hydroxide)-methanol and acetonitrile (4 :1), the flow rate was 1. 0 ml·min-1 , the column temperature was 30℃, the detection wavelength was 260 nm, and the injection volume was 10 μl. Results:Flibanserin and all the related compounds could be well separated. The linear range was 20-500 μg·ml-1(r=0. 9998), the average recovery was 100. 0%(RSD=0. 90%,n=9). The content of the main component in 4 batches of samples was 99. 6%, 99. 8%, 100. 4% and 99. 4%, respectively. The single impurity limit was set at 0. 1% and the limit of total impurities was set at 0. 5%. Con-clusion:The method is specific and accurate, which can be applied in the determination of content and related substances of fliban-serin.
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Objective To develop a method for detection of avanafil and flibanserin adulterated in health food by high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS).Methods The separation and analysis were performed on an Agilent Eclipse Plus C18 column(2.1 mm×100 mm,1.8 μm),with a mobile phase of acetonitrile and 0.1%acetic acid(containing 20 mmol·L-1 ammonium acetate)(60:40).Electrospray ionization(ESI) source was applied and operated in positive mode.Multiple reaction monitoring(MRM) mode was used to quantify avanafil and flibanserin.Results The assay linearity of avanafil and flibanserin were confirmed in the range of 2-20 ng·mL-1(r2>0.99).The extraction recoveries varied from 94.6% to 110.0%,and the precision of RSD was <5.0%.The limits of detection were 0.21 and 0.42 μg·kg-1 for avanafil and flibanserin,respectively.Conclusion The method was specific,sensitive and accurate.Therefore,it can be used to detect avanafil and flibanserin which were illegally added in health food.
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Low sexual desire is a very common symptom in women of any age with potential negative consequences on quality of life and well-being according to The American Psychiatric Association’s Diagnostic, Statistical Manual of Mental Disorders (DSM-IV TR) and the World Health Organization’s International Classifications of Disease. They also established that the definition of hypoactive sexual desire disorder (HSDD) should include not only the lack or absence of sexual fantasies or desire for any form of sexual activity, but also the presence of personal distress and/or interpersonal difficulties. Flibanserin, a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) was used in most of the pre-menopausal women diagnosed with Hypoactive Sexual Desire Disorder (HSDD) but its approval also faced a little scepticism.
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There have been several products developed for male sexual dysfunction. However, developing agents for female sexual dysfunction is lagging behind for various reasons. Sildenafil citrate (Viagra) and Tadalafil (Cialis), which have been prescribed for male sexual function disorders, are known to act on vessels.[1] On the other hand, flibanserin is thought to act on brain. Flibanserin has been approved by U. S. Food and Drug Administration (FDA) for treatment of hypoactive sexual desire disorder (HSDD) of premenopausal women in 2015, and is expected to be released in South Korea soon. Authors wrote this article to acknowledge flibanserin to sexologists for females or physicians for menopausal medicine, so that this agent can be safely used for females who have HSDD.