Abstract
In substandard drugs enforcement, there is a need to develop reliable, fast, and inexpensive analytical methods. Due to its very characteristics, HPTLC offers opportunities for the development of methods that meet these requirements. This technique was used to develop and validate a method for the determination of sildenafil in pharmaceutical formulations from the licit and illicit supply chain in Burkina Faso. Taking into account optimization parameters such as measurement wavelength and mobile phase composition, the best elution quality is found at the maximum signals of spots on silica plates at 305 nm, using a mixture of dichloromethane-methanol mixture 9 : 1 (v/v) proportions. The method developed under these conditions was validated using the accuracy profile as a decision tool. The establishment of the response function curves allowed the choice of the polynomial function applied to the peak areas. This mathematical model provides a validity range between 0.4 and 0.6 mg/mL. The application of the developed and validated method to collected samples allowed the detection of two substandard drugs and confirmed the poor quality of drugs in the illicit market. More data using this approach in a variety of drug molecules could lead to the establishment of databases of counterfeit drugs in Burkina Faso.
Highlights
Data from the literature show that the market share of illicit or falsified drugs is estimated at 10% with an increasing trend in some countries
Falsified or poor quality medicines are a serious concern to public health worldwide, especially for developing countries where surveillance systems are weak and quality control of drugs is inefficient. e quality control of medicines is generally based on the monographs of the different pharmacopoeias and from WHO
Counterfeiting analysis can be done by simple visual inspection or through the use of sophisticated techniques including imaging, spectrometric, and chromatographic techniques. e analytical methods to be used are classified into two main groups: destructive methods and nondestructive methods; the latter can be performed outside the laboratory
Summary
Data from the literature show that the market share of illicit or falsified drugs is estimated at 10% with an increasing trend in some countries. Falsified or poor quality medicines are a serious concern to public health worldwide, especially for developing countries where surveillance systems are weak and quality control of drugs is inefficient. It is necessary to have simple, fast, and efficient methods for the analysis of suspect products, and High-Performance in-Layer Chromatography (HPTLC), by its very characteristics, offers. Due to its relatively affordable cost per analysis, it appears to be an excellent alternative adapted to the context of developing countries, to control the quality of various products, pharmaceuticals. HPTLC has already been successfully implemented in these countries for the quality control of various pharmaceutical products such as antituberculosis, antibiotics, antifungals, and antiretroviral drugs [12, 13]. We developed and validated a method for the analysis of pharmaceutical formulations of sildenafil from the licit and illicit distribution chain, using HPTLC. is molecule is a phosphodiesterase type 5 inhibitor, used in erectile dysfunction, which since its introduction has been frequently used in adulterations of herbal products and dietary supplements [14,15,16]. is study will contribute to generating data on the issue of counterfeiting in Burkina Faso
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