Bromhexine Determination by Diazotization Using Potentiometric Titration: Application to Content Uniformity

Abstract

Bromhexine hydrochloride was diazotized in the presence of hydrochloric acid using 0.1M sodium nitrite. The end point was monitored utilizing controlled titrator equipped with double pin platinum electrode and polarizing current generator. The effects of acid type, strength, polarizing current and the sample weight on determinations were studied. Hydrochloric and sulphuric acids were found to be essential for the diazotization while glacial acetic acid was not effective. Execution of diazotization was delayed in the presence of sulphuric acid. Samples of 100 mg suffered from the sulphuric acid strength variation which was not effective on weights over 400 mg. Hydrochloric acid strength had significant effect on samples having weights in the proximity of 4 mg, while samples over 100 mg were not affected. The polarizing current in crease caused adecrease in the titration time and higher content was obtained. The reported method was appliedto the bulk drug and tablets. When compared with B.P. current method, it was found to have an equivalent reproducibility. Further more, the method was used for Content uniformity of tableS and for the non pharmacope-ial dosage forms. This method is simple, fast, reproducible and applicable for automation.

Key Words:

• Bromhexine Hydrochloride
• Diazotization
• Assay
• Content Uniformity