Estimation of Salbutamol, Bromhexine, Guaifenesin, Methyl hydroxybenzoate and Propyl hydroxybenzoate in Multicomponent Cough Expectorant syrup by HPLC

Abstract

Background:Bronkovent syrup is a medication used to treat various respiratory conditions by addressing the underlying mucus and airflow issues. It contains a combination of active ingredients that work together to provide relief.

The key components of Bronkovent syrup are:

• Salbutamol (2 mg per 5 mL): This opens the constricted airways without affecting the heart.
• Bromhexine hydrochloride (4 mg per 5 mL): This thins out mucus in the airways to facilitate clearing.
• Guaifenesin (50 mg per 5 mL): This expectorant increases sputum volume and reduces its viscosity, making it easier to cough up.
• Methyl and propyl hydroxybenzoates: These are preservatives.

Bronkovent syrup is indicated for use in acute and chronic respiratory conditions, including bronchial asthma, bronchiectasis, and whooping cough, where it helps clear thick, sticky mucus from the lungs.

Aim:To develop a simple, rapid, and cost-effective HPLC methodology for the simultaneous determination of Salbutamol, Bromhexine hydrochloride, Guaifenesin, Methyl hydroxybenzoate, and Propyl hydroxybenzoate in multi-component cough expectorant syrup, and to validate the method.

The method involves diluting the sample with a simple diluent and analyzing it using an HPLC system equipped with a UV detector and a Waters X-Bridge column (250 x 4.6 mm, 5 μm) coupled with a Ghost buster column (50 x 4.6 mm). The flow rate was set at 1.2 mL/min with a gradient elution. The column oven and autosampler temperatures were maintained at 40°C and 10°C, respectively, with an injection volume of 10 μL. The retention times for the analytes were approximately 11minutes for Salbutamol, 28minutes for Bromhexine hydrochloride, 16minutes for Guaifenesin, 19minutes for Methyl hydroxybenzoate, and 26minutes for Propyl hydroxybenzoate.

Results and discussion:The developed method was validated according to the ICH guidelines and the values of accuracy, method precision and other statistical analysis were found to be in good accordance with the specified acceptance criteria.

Conclusion:The proposed methodology was successfully applied to the determination of Salbutamol, Bromhexine hydrochloride, Guaifenesin, Methyl hydroxybenzoate, and Propyl hydroxybenzoate in Bronkovent syrup by GC-FID for routine analysis.