Validation of analytical method for determination of microbiological quality of antifungal shampoo containing 2% ketoconazole: Enumeration test and tests for specified microorganisms (Method suitability test)
Year: 2024
Type: article
Abstract: Microbiological quality screening of non - sterile product is conducted by suitable enumeration tests and tests for absence of specified microorganisms. The European Pharmacopoeia offers several methods for conducting these tests. The suitability of a compendial microbiological method must be demonstrated to ensure accuracy and reliability of test results. The work presented here had the purpose of creating a validated and reliable method for screening the microbiological quality of antifungal shampoo containing 2% ketoconazole. Method suitability tests for the parameters: Total aerobic microbial count (TAMC), Total yeast and mold count (TYMC), absence of Staphylococcus aureus and Pseudomonas aeruginosa were determined according to chapters 2.6.12. Microbial examination of non – sterile products: microbial enumeration tests and 2.6.13. Microbial examination of non – sterile products: test for specified microorganisms. The membrane filtration method was chosen for TAMC and TYMC. The criteria for method suitability of the counting methods TAMC and TYMC – a mean count of each of the microorganisms differing by a factor not greater than 2 from the value of the control in the absence of the product (recovery rate 50% - 150% of the test group with product in comparison with the positive control group) was obtained. The criteria of growth on selective media for P. aeruginosa and S. aureus were also obtained.
Authors: Nadica Gjurichikj, Julija Gjorchevska Aceska, Maja Veljanovska Todorovska, Tatjana Gjurichikj, Liljana Anastasova, Rumenka Petkovska
Institution: Ss. Cyril and Methodius University in Skopje
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6927546963
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