Spectrophotometric Determination of Bromhexine HCl in Pure and Pharmaceutical Forms

K Susmitha,M Thirumalachary,G Venkateshwarlu

doi:10.1155/2013/861851

Abstract

Five spectrophotometric methods for determination of bromhexine HCl have been developed, validated, and applied for the assay of the drug in pharmaceuticals. Methods A, B, and C are based on ion-pair complexation of drug, in acidic buffers, with triphenylmethane dyes, namely, bromothymol blue (BTB), bromophenol blue (BPB), and bromocresol green (BCG). The complexes are extracted into chloroform, and absorbance is measured at around 415 nm as function of concentration of the drug. The stoichiometry of the complex is found to be 1 : 1 in each case. Method D depends upon charge-transfer complexation of neutralized drug with iodine which produces iodide ion whose absorbance at 366 nm is measured as function of concentration of the drug. This complex too has 1 : 1 composition as determined by Job’s method. Method E is developed on the basis of oxidation of the drug with alkaline KMnO4 which generates green-colored manganate ion with 610 nm. As the intensity of green color increased with increasing time kinetics of the reaction is followed, and calibration curves are constructed by using initial rate and fixed time methods. Excellent recovery studies with high accuracy and precision indicate that the methods can be successfully used in industries for the assay of drug in pure form and pharmaceuticals.

Highlights

Bromhexine HCl (BRH), chemically named 2-amino-3,5dibromo-N-cyclohexyl-N-methyl benzenemethanamine hydrochloride, is a mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus [1, 2]
Thorough survey of the literature showed that the quantification methods of our interest are not reported yet, and in the present communication we report five quantification methods, namely, A, B, C, D, and E, that have been developed and validated for quantification of bromhexine HCl both in pure and pharmaceutical forms
The methods A, B, and C are based on the interaction of the drug with bromothymol blue (BTB), bromophenol blue (BPB), and bromocresol green (BCG), respectively, to form chloroform-extractable ion pair complexes (Scheme 1) which absorb around 415 nm (Figure 1)

Summary

Introduction

Bromhexine HCl (BRH), chemically named 2-amino-3,5dibromo-N-cyclohexyl-N-methyl benzenemethanamine hydrochloride, is a mucolytic agent used in the treatment of respiratory disorders associated with viscid or excessive mucus [1, 2]. The drug has been quantified in its combined formulations using HPLC [15,16,17,18], direct and derivative UV spectrophotometry [19,20,21,22,23]. These methods involve scarcely available costly equipment and tedious experimentation. Accurate, and precise methods using spectrophotometry have been developed based on the production of chromophore by the interaction of the drug with an analytical reagent, as chromogen [24,25,26]. Thorough survey of the literature showed that the quantification methods of our interest are not reported yet, and in the present communication we report five quantification methods, namely, A, B, C, D, and E, that have been developed and validated for quantification of bromhexine HCl both in pure and pharmaceutical forms

Experiment

Method E

Calibration Curve for Method E

Assay of Drug in Pharmaceuticals

Results and Discussion

Conclusions