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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.
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
January 1985,
Journal of pharmaceutical and biomedical analysis,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
August 1996,
Journal of pharmaceutical and biomedical analysis,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
November 2002,
Farmaco (Societa chimica italiana : 1989),
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
June 1979,
Journal of pharmaceutical sciences,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
October 1981,
The Analyst,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
January 1987,
Journal of pharmaceutical and biomedical analysis,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
July 1976,
Journal of pharmaceutical sciences,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
March 1977,
Journal of pharmaceutical sciences,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
May 1977,
Journal of pharmaceutical sciences,
J G Hoogerheide, and
S H Strusiak, and
C R Taddei, and
E R Townley, and
B E Wyka
November 1988,
Il Farmaco; edizione pratica,
