High performance liquid chromatographic determination of clotrimazole in pharmaceutical formulations.

A simple stability-indicating high performance liquid chromatographic (HPLC) method has been developed which separates clotrimazole from impurities and decomposition products in bulk drugs, creams, tablets, and solutions. Average recovery data for drug substance added to placebos were: tablet, 99.8%; solution, 99.5%; and cream, 100.0%. Average reproducibilities (RSD) on drug substance and formulations were: drug substance, 1.3%; tablets, 1.8%; solutions, 1.1%; and creams, 0.6%. HPLC assay results for both fresh and degraded samples agree with USP XX titration assay results. The method allows for the simultaneous determination of (o-chlorophenyl)diphenylmethanol hydrolysis product impurity.