DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF MUPIROCIN IN BULK AND OINTMENT DOSAGE FORM

Gunasekar Manoharan*

ABSTRACT

A simple, gradient RP- HPLC method has been developed and validated for Mupirocin in bulk and ointment formulation. The successful estimation was carried out of the drug product is developed on C(18) column reversed-phase using Methanol: Phosphate buffer (20:80 v/v) as mobile phase composition. The flow rate was adjusted to 1.0 mL/minute and the absorption maxima were observed at 270 nm utilizing Shimadzu SPD-20A Prominence UV-Vis detector. Mupirocin showed a good and precise linearity in the range 20-100 μg/mL. The HPLC, assay shows the purity ranging 98.95 to 103.07% for ointment formulation. The mean percentage purity is 101.47%. The chromatographic retention time of Mupirocin was found to be 7.3 minutes. The statistical analysis shows the method accuracy. Various forced degradation studies was conducted on Mupirocin ointment to examine the stability of the drug. The developed method validated according to the ICH guidelines.

Keywords: Mupirocin, RP-HPLC, UV, Validation and forced degradiation.