Clotrimazole is an imidazole antifungal drug which are available in various dosage forms such as creams, topical solutions and vaginal tablets. In the fiscal year 2018, the quality assessment of Clotrimazole was evaluated in accordance with the United States Pharmacopeia (USP 40). The method was verified prior to sample testing. A total of 176 samples were collected from public hospitals and manufacturers. 65 samples of creams were tested for assay and microbial examination. The results showed that 1 sample failed microbial examination. 6 samples of topical solutions were tested for assay, organic impurities and microbial examination and it was shown that 3 samples failed organic impurities. 105 samples of vaginal tablets were tested for assay, uniformity of dosage units, disintegration and organic impurities. The results showed that 52 samples failed organic impurities and disintegration.
Keywords: Clotrimazole, tablets, solution, cream, quality