Simultaneous HPLC method development and validation of moxifloxacin hydrochloride and bromofenac sodium in pharmaceutical formulation

Abstract

This paper deals with the simultaneous reversed – phase HPLC method development for the for the simultaneous
determination of Moxifloxacin Hydrochloride and Bromofenac Sodium in Pharmaceutical preparation. The
chromatographic separation was carried out using a STD Hyber C18 column, 150× 4.6mm i.d, 5µ particle size in isocratic
mode with flow rate of 1mLmin-1
and the detection was carried out by Photo diode array detector at 280nm. The mobile
phases consist of 0.01N Sodium Dihydrogen Ortho Phosphate buffer (pH 4 ±0.5) and Acetonitrile in the ratio of 65:35
(v/v). The total chromatographic analysis per sample was approximately 6 mints. Retention times for Moxifloxacin
Hydrochloride and Bromofenac Sodium were found to be 2.26 and 5.72 min respectively. A linear response curve was
observed over the concentration range of 25-150µgmL-1
and 4.5-27µgmL-1
for Moxifloxacin Hydrochloride and
Bromofenac Sodium. The method was statistically validated as per ICH guidelines and % RSD was found to be less than 2
indicating high degree of accuracy and precision of the proposed HPLC method. Hence the proposed method can be
applied for the quantitative analysis of Moxema and Bromday eye drops.