Stability study of metronidazole cream, extemporous made in pharmacy

The aim of investigation: To determine the stability and shelf life of metronidazole cream. Objectives: 1. To evaluate the influence of various physical factors on the stability of metronidazole cream; 2. Select the conditions of the liquid chromatographic method for qualitative and quantitative evaluation of metronidazole; 3. To perform a qualitative and quantitative analysis of the metronidazole cream; 4. Perform a microbiological examination of metronidazole cream. The object of investigation: Metronidazole 2% cream. Methods: Long-term stability study of metronidazole cream at 25 ± 2 ° C, 60 ± 5% relative humidity; accelerated stability test at 40 ± 2 ° C, 75 ± 5 % relative humidity, high performance liquid chromatography; the influence of stress conditions (acidic media, alkaline media, hydrogen peroxide, heat, light) on the stability of metronidazole cream; metronidazole cream texture analysis for lubrication and ejection tests; microbiological examination. Results and conclusions: 1. The influence of various physical factors on the stability of metronidazole cream has been evaluated. It was found that color (white), odor (odorless), integrity (homogeneous), pH (6,8) did not change during storage of metronidazole (6 months). Mechanical properties of the metronidazole cream: firmness, shear, consistency and cohesion throughout the study remained stable. 2. The most suitable liquid chromatographic conditions were selected using 20% methanol for extraction. 3. High performance liquid chromatography in the full stability study (6 months long-term stability and 6 months accelerated stability) showed that metronidazole concentrations did not fluctuate within ± 5%, so the cream remained stable for 6 months. Stress factors, such as, acid media, alkaline media, hydrogen peroxide, daylight and heat did not affect the stability of the cream. 4. A microbiological examination of the metronidazole cream meet european pharmacopoeia requirements: total aerobic microbial count of 102 CFU/g, the total yeast/mold count does not exceed 101 CFU/g and the traces of Staphylococcus aureus and Pseudomonas aeruginosa were found for whole cream storage process