Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF MUPIROCIN AND METRONIDAZOLE IN COMBINED DOSAGE FORM BY RP-HPLC

Y. Anuradha*, P. Venkateswara Rao, B. Thangabalan

ABSTRACT

A simple, rapid reverse - phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Mupirocin and Metronidazole in pure and in colloidal dosage form. The estimation was carried out on a Phenomenex C-18 (240~4.6mm, particle size 5ƒÊm) column with a mixture of 0.1 % ortho phosphoric acid buffer : methanol (50:50) (v/v) as mobile phase. UV detection was performed at 220 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 2.90 and 4.18 min for Mupirocin and Metronidazole respectively. The flow rate was 1.0 mL/min. The calibration curve was linear over the concentration range of 20-500 ƒÊg/mL for Mupirocin and 10-250 ƒÊg/mL for Metronidazole. The LOD and LOQ values were found to be 0.7344 and 2.256 ƒÊg/mL for Mupirocin and 0.01171 and 0.0335 ƒÊg/mL for Metronidazole respectively. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the simultaneous estimation of Mupirocin and Metronodazole in pure and its dosage form.

Keywords: Mupirocin, Metronidazole, RP-HPLC, Validation.