Method suitability validation for determination of microbiological purity of Sildenafil film-coated tablet
Abstract
Sildenafil is a medication used to treat pulmonary arterial hypertension and erectile dysfunction. It is taken by mouth or by injection into a vein. Onset is typically within twenty minutes and lasts for about two hours. Mechanism of act of sildenafil is by blocking phosphodiesterase 5 (PDE5), an enzyme that promotes breakdown of cGMP, in the smooth muscle cells lining the blood vessels supplying various tissues. It also results in dilation of the blood vessels in the lungs (Cocci et al., 2017). All pharmaceutical forms are subject to chemical and microbiological quality control. A microbiological quality control method that will be used in routine analysis for determination of product microbiological purity must be subject of validation. Microbiological quality control parameters for Sildenafil film coated tablets 100 mg as non-aqueous pharmaceutical preparation for oral use are: Total Aerobic Microbial Count (TAMC), Total Yeasts and Molds Count (TYMC) and Absence of Escherichia coli (Ph.Eur. 10.0, 2019).
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