Development and stability test of compound ketoconazole ointment / 药学实践杂志

ABSTRACT

Objective To prepare compound ketoconazole ointment and perform the stability study .Methods Ketocon-azole ,mupirocin and mometasone furoate were used as active pharmaceutical ingredients (API) .PEG mixture was used as ma-trix to prepare the ointment .Stability of the API in the ointment was evaluated by the stress tests .Results The optimal ratio of PEG400 to PEG3350 for the ointment matrix was 21 .Mometasone furoate and mupirocin in the ointment were stable to the high temperature(40 ℃)while ketoconazole had some degradation .The stability of the API was improved by addition of 0 .5％ of L-A .During the accelerate test ,the ointment had no color change and the API percentages were above 98％ .Conclu-sion The novel compound ketoconazole ointment was successfully prepared and the formulation stability was excellent .