LIQUID CHROMATOGRAPHY METHOD FOR SEPARATION OF CHLORAMPHENICOL PALMITATE AND ITS RELATED SUSTANCES

Abstract

Hitherto, the official methods of assay chloramphenicol palmitate raw material and its suspension are not specific enough to separate the active pharmaceutical ingredient (API) from its related substances. The dual- purpose advantage of cyano column (250mmX4.6mm, 5µ) has been explored for a specific assay of chloramphenicol palmitate raw material raw material and suspensions with separation from the related substances. The reverse phase isocratic elution (methanol: water: glacial acetic acid 63:36.9:0.1) at 2mL/min separated chloramphenicol palmitate from free chloramphenicol, chloramphenicol palmitate isomer and chloramphenicol dipalmitate but could not separate chloramphenicol palmitate. Four brands of chloramphenicol suspension were assayed for content of active ingredient. The method is accurate (100%), specific and precise with intra-day precision of 0.46% and inter-day of 0.57%. On the other hand, the normal phase mode (methanol: chloroform: cyclohexane- 10:40: 50) at lmL/min separated chloramphenicol palmitate from free chloramphenicol and chloramphenicol dipalmitate but could not separate chloramphenicol palmitate from its isomer. Thus, the new reverse phase mode represents an improvement on USP method in the separation of chloramphenicol palmitate from its related substance. Out of the four brands of chloramphenicol suspension examined for content of active ingredient only one of them complied with the USP assay requirement. On the important limit of polymorph A, inter- batch variation was observation for two brands while the other two brands passed consistently

Author

Adeagbo, B. A. and *Olugbade, T. A. - Department of Pharmaceutical Chemistry Faculty of Pharmacy, Obafemi Awolowo University, Ile-ife