Method suitability validation for determination of microbiological purity of Ciprofloxacin film-coated tablet

Ciprofloxacin belongs to the group of fluoroquinolone antibiotics, used to treat a number of bacterial infections. This includes bone and joint infections, intra-abdominal infections, certain types of infectious diarrhea, respiratory tract infections, skin infections, typhoid fever, and urinary tract infections, among others (Solomkin et al. 2010). Ciprofloxacin occupies an important role in treatment guidelines issued by major medical societies for the treatment of serious infections, especially those likely to be caused by Gramnegative bacteria, including Pseudomonas aeruginosa. For example, ciprofloxacin in combination with metronidazole is one of several first-line antibiotic regimens recommended by the Infectious Diseases Society of America for the treatment of communityacquired abdominal infections in adults (Solomkin et al., 2010). It also features prominently in treatment guidelines for acute pyelonephritis, complicated or hospital-acquired urinary tract infection, acute or chronic prostatitis (Grabe et al., 2013). All pharmaceutical forms are subject to chemical and microbiological quality control. A microbiological quality control method that will be used in routine for determination of product microbiological purity must be subject of validation. Microbiological quality control parameters for Ciprofloxacin 500 mg film-coated tablet 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). Мaterials and methods