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Determination of tretinoin in creams by high-performance liquid chromatography
M B Kril1, K A Burke, J E DiNunzio
1Bristol-Myers Squibb Co., Pharmaceutical Research Institute, Buffalo, NY 14213.
Journal of Chromatography
|November 28, 1990
Abstract:
A stability indicating reversed-phase high-performance liquid chromatographic method has been developed to quantify tretinoin (all-trans-retinoic acid) in cream formulations. Tretinoin cream samples were dissolved directly in tetrahydrofuran and diluted for injection. Separation was accomplished on a 15 cm Nova-Pak C18 column using a tetrahydrofuran-phosphate buffer solvent system (42:58, v/v) and 1.0 ml/min flow-rate. The method is able to separate tretinoin from its degradation products formed under stressing conditions. Excellent precision and accuracy were found for the assay of tretinoin in the cream formulations.