A rapid HPLC method for simultaneous determination of tretinoin and isotretinoin in dermatological formulations.
A rapid method using an isocratic high-pressure liquid chromatography and UV detection for determination of both all-trans retinoic acid (tretinoin) and 13-cis retinoic acid (isotretinoin) in dermatological preparations is presented. Tretinoin and isotretinoin samples were extracted with acetonitrile by a procedure that can be completed in less than 10 min. Subsequent separation and quantification of amounts as low as 10 pmol was accomplished in less than 15 min using reversed-phase HPLC with isocratic elution with 0.01% trifluoroacetic acid (TFA)/acetonitrile (15:85, v/v). Validation experiments confirmed the precision and accuracy of the method. When applied to commercial tretinoin samples, recoveries of 104.9% for cream formulations and 107.7% for gel formulations were obtained. Application of the method for analysis of a tretinoin cream exposed to solar simulated light (SSL) demonstrated detection of the major photoisomerization product isotretinoin as well as 9-cis retinoic acid, demonstrating the utility of the method for studies of tretinoin photostability. The method should also facilitate studies of the formulation compatibility and photocompatibility of tretinoin with agents that may improve its clinical tolerability.
Tashtoush
Bassam M
BM
Department of Pharmaceutical Technology, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.
Jacobson
Elaine L
EL
Jacobson
Myron K
MK
D000097:Acetonitriles / Q000032:analysis; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D003879:Dermatologic Agents / Q000032:analysis*; D004344:Drug Incompatibility; D004355:Drug Stability; D005782:Gels; D015474:Isotretinoin / Q000032:analysis*; D007641:Keratolytic Agents / Q000032:analysis*; D009824:Ointments; D010777:Photochemistry; D011786:Quality Control; D012044:Regression Analysis; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013472:Sunlight; D014212:Tretinoin / Q000032:analysis*; D014269:Trifluoroacetic Acid / Q000032:analysis
D000097:Acetonitriles; D003879:Dermatologic Agents; D005782:Gels; D007641:Keratolytic Agents; D009824:Ointments; D014212:Tretinoin; D014269:Trifluoroacetic Acid; D015474:Isotretinoin; C032159:acetonitrile