Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF BROMHEXINE HYDROCHL ORIDE, GUAIPHENESIN AND CHLORPHENIRAMINE MALEATE IN TABLET.

Ankit B. Chaudhary*, Shweta M. Bhadani, Chintal M.Shah

ABSTRACT

A Reverse Phase High Performance Liquid Chromatographic method was developed for the simultaneous estimation of Bromhexine Hydrochloride, Guaiphenesin and Chlorpheniramine Maleate. The separation was achieved by C18 column (250×4.6 mm, 5 μm Particle Size) with the mobile phase consisting of 0.01 M Potassium dihydrogen Phosphate Buffer pH-3 adjusted with 1% of Ortho Phosphoric Acid: Acetonitrile (40:60% v/v). Detection was carried out at 254 nm. RP-HPLC method gives retention time of Bromhexine Hydrochloride (BH), Guaiphenesin (GP) and Chlorpheniramine Maleate (CPM) was found to be 5.54min, 2.03min and 6.61 min respectively. The method has been validated for ICH Guideline. Linearity for Bromhexine Hydrochloride, Guaiphenesin and Chlorpheniramine Maleate were found in the range of 10-60 μg/ml, 125-750μg/ml and 5-30 μg/ml. The percentage recoveries obtained for BH, GP and CPM were found to be in range of 99.40-101.95%, 100.63-101.51% and100.64-101.51% respectively in tablet. Limit of detection and Limit of quantification was found to be 1.449μg/ml and 4.830μg/ml for BH, 15.02μg/ml and 50.08μg/ml for GP and 0.795μg/ml and 2.651μg/ml for CPM respectively.

Keywords: Reverse Phase High Performance Liquid Chromatography Method (RP-HPLC), Bromhexine Hydrochloride (BH), Guaiphenesin (GP) and Chlorpheniramine Maleate (CPM)