Development and Validation of Analytical Method for Simultaneous Estimation of Bromhexine HCl and Enrofloxacine in Combined Pharmaceutical Dosage Form

Abstract

A simple, accurate, precise RP-HPLC method has been developed and validated for the
simultaneous estimation of Bromhexine HCl and Enrofloxacin in their combined tablet
dosage form. The combination used for the Separation is ENROLIQ-B. Separation was
performed on a C18 column [Hypersil BDS C18 column, 250 x 4.6 mm], with 0.05 M
KH2PO4 Buffer pH 6: Methanol: Triethylamine (70:30:0.1 %v/v/v) as a mobile phase and
flow rate was kept at 1 ml/min. Good sensitivity was found with UV detection at 261.00
nm. After method development the interference with the active compounds and
excipients, repeatability and linearity were investigated. ReBROMtion times were found
to be 3.190 and 5.067 min. respectively, for BROM and ENR. The method was validated
over the analytical range from 1.5-4.5μg/ml for BROM (r2=0.998) and 20-60 μg/ml for
ENR (r2=0.999). This method showed good reproducibility and recovery with %RSD in
the desired range. The proposed method can be successfully applied for the routine
analysis of both drugs in their combine dosage form.