高效液相色谱法测定药物制剂中的克霉唑
High performance liquid chromatographic determination of clotrimazole in pharmaceutical formulations.
作者信息
Hoogerheide J G, Strusiak S H, Taddei C R, Townley E R, Wyka B E
出版信息
J Assoc Off Anal Chem. 1981 Jul;64(4):864-9.
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.
已开发出一种简单的稳定性指示高效液相色谱（HPLC）方法，可将克霉唑与原料药、乳膏、片剂和溶液中的杂质及分解产物分离。添加到安慰剂中的原料药的平均回收率数据为：片剂99.8%；溶液99.5%；乳膏100.0%。原料药和制剂的平均重现性（相对标准偏差）为：原料药1.3%；片剂1.8%；溶液1.1%；乳膏0.6%。新鲜样品和降解样品的HPLC测定结果与USP XX滴定法测定结果一致。该方法可同时测定（邻氯苯基）二苯基甲醇水解产物杂质。
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