ABSTRACT:
The aim of the present work was to determine the active pharmaceutical ingredient of samples of povidone-iodine solutions 10% (topical solution and vaginal douche), which were obtained from market in Syria (A, B, C) for povidone-iodine 10% topical solution and (D, E, F) for povidone-iodine 10% vaginal douche and one solution produced by Mundipharma Company (Betadine 10% topical solution and Betadine 10% vaginal douche), which used as a reference. The research included control of solutions pH and free iodine concentration. In addition, the factors affecting stability of previous solutions and control stability of samples during the date of validity were studied. The results obtained showed that only 50% of the samples evaluated were within the iodine concentration range required. For povidone-iodine 10% topical solution, sample (A) was the closest to Betadine 10% topical solution, which had the highest level. Study revealed significant difference between local companies, where (A) had the best bactericidal effect. In addition, stability study of samples revealed that 50% of samples showed a significant decrease in iodine content in the second year of validity. For povidone-iodine 10% vaginal douche, the sample (E) was the closest to Betadine 10% vaginal douche, which had the highest level. Study revealed significant difference between local companies, where (E) had the best bactericidal effect. In addition, stability study of samples revealed that 50% of samples showed a significant decrease in iodine content in the second year of validity. The pH values of the local samples solutions were within the range (1.5-6.5) of activity and stability.