Analysis of the nitrogen mustard mechlorethamine in topical pharmaceutical preparations by high-performance liquid chromatography.
Mechlorethamine in topical pharmaceutical formulations was derivatized with benzenethiol to form the disubstitution product and analyzed by normal-phase HPLC on silica gel using dibutyl phthalate as an internal standard. The derivatization reaction, purification, and isolation were conveniently performed in a single test tube. Analyses were successfully performed on three types of ointment formulations: anhydrous hydrophobic petrolatum-based ointments, anhydrous hydrophilic ointments, and hydrous hydrophilic ointments. Precision for the analysis of mechlorethamine standard or mechlorethamine in ointments ranged from 0.08 to 0.52% RSD (n = 6). Recoveries from ointments spiked with 0.02% mechlorethamine hydrochloride were 98.4-100.4%. The chromatograms were clean, showing minimal or no interference from ointment excipients or reagents.
Reepmeyer
John C
JC
U.S. Food and Drug Administration, Division of Pharmaceutical Analysis, St. Louis, MO 63101, USA. reepmeyerj@cder.fda.gov
D000287:Administration, Topical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D008466:Mechlorethamine / Q000032:analysis* / Q000737:chemistry; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry*; D010636:Phenols / Q000737:chemistry; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization; D013056:Spectrophotometry, Ultraviolet; D013438:Sulfhydryl Compounds / Q000737:chemistry
D004364:Pharmaceutical Preparations; D010636:Phenols; D013438:Sulfhydryl Compounds; D008466:Mechlorethamine; C042983:thiophenol