Abstract
Objective: Investigation of sildenafil citrate as an adulterant in the traditional liquid herbal products of the local market in Bangladesh.Methods: A reversed-phase high-performance liquid chromatographic (HPLC) method with photodiode array (PDA) detector system has been developed and validated for investigating the presence of synthetic phosphodiesterase 5 (PDE-5) enzyme inhibitor as an adulterant in the traditional herbal products. Nine of the liquid preparations (syrup), Balarista (A), Jinsant (B), Jernide (C), Bolarist (D), Sree Gopal Oil (E), Menostroge (F), Enerton (G), Ginseng (H) and Ginsin Plus (I), of six companies form local market of Bangladesh were investigated.Results: All the products (A–I) were found to contain sildenafil citrate as an adulterant. HPLC peak of the adulterant was confirmed by comparing retention time, UV spectra generated by PDA detector and peak spiking with the authentic sample of sildenafil citrate. The quantity of sildenafil citrate in A, B, C, D, E, F, G, H and I syrups were found to be 17, 22, 26, 25, 10, 24, 29, 22 and 17 mg/100 ml, respectively.Conclusion: The study indicated that all tested liquid herbal products contain sildenafil citrate as an adulterant. As PDE-5 inhibitors have severe side effects, possess drug-drug interaction and highly recommended to prescribe by registered physicians, the regulatory agency of Bangladesh should take necessary action to minimize the risk of patients.
Highlights
PDE is a ubiquitous enzyme in the human cell that is the essential regulators of cyclic nucleotide signalling with diverse physiological functions
We investigated the presence of specific phosphodiesterase 5 (PDE-5) inhibitor in the most popular marketed liquid herbal products in Bangladesh by high-performance liquid chromatographic (HPLC) system to confirm their safe use
To evaluate the limit of detection (LOD) and limit of quantification (LOQ), the different concentrations of the standard were mixed in blank herbal products
Summary
PDE is a ubiquitous enzyme in the human cell that is the essential regulators of cyclic nucleotide signalling with diverse physiological functions. 11 subtypes of PDE (1–11) were identified. These enzymes are involved in various regulatory processes like ionchannel functions, cell differentiation, apoptosis, muscle contraction etc. Sildenafil serendipitously found to have an effect in penile engorgement. This drug was eventually approved by Food and Drug Administration (FDA) of USA in1998 for the treatment of ED. As PDE–6 is found in the retinal cell, use of sildenafil is associated with visual side effects [2]. Sildenafil showed several drug-drug interactions and contraindicated to organic nitrates. Concomitant use of sildenafil and organic nitrates might cause severe and fatal hypotension [3]
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