ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF MUPIRICON OINMENTS BY RP-HPLC METHODS

A simple, economical, specific, accurate, precise and validated reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed for the assay study of Mupirocin Ointment in the pharmaceutical dosage form. The chromatographic separation was achieved on C-18 column (300 mm x 3.9 mm, 10 µ particle size) at 25℃ temperature using mobile phase Phosphate Buffer : Acetonitrile(ACN) (75:25 % v/v) at flow rate 1.0 ml/min. Quantification was achieved with a UV detector at 229 nm. The retention time of Mupirocin USP was found to be 6.696 ± 0.05 min. The proposed method was validated according to ICH guidelines concerning assay studies for Mupirocin ointment. The developed method with good separation successfully applied for the determination of Mupirocin in its pharmaceutical dosage form. Keywords : RP-HPLC, Mupirocin, Assay, Chromatography, ICH Guidelines.