New stability indicating RP-HPLC method for the simultaneous estimation of terbutaline sulphate and bromhexine hydrochloride in tablet dosage form

Abstract

Bromhexine hydrochloride in combination with Terbutaline Sulphate is used as a fast-acting bronchodilator. New stability indicating RP- HPLC method was developed for the simultaneous estimation of Terbutaline Sulphate and Bromhexine Hydrochloride in Tablet dosage form. A Shimadzu Prominence liquid chromatograph with LC-20 AT pumping system and SPD-20, A UV-Vis Detector, was used for the proposed method. The chromatography was performed in reverse phase mode using a Phenomenex Luna C-18 column (4.5 x 150 mm, 5µm) as stationary phase and isocratic mobile phase constituting of 0.1% v/v Perchloric acid: Acetonitrile (60 vol :40 vol) at a flow rate of 1.5 ml/ min with UV detection at 254 nm. The developed RP- HPLC method demonstrated good linearity in the concentration range of 10-60µg/ml for Terbutaline Sulphate with R2=0.9991 and 20-100µg/ml for Bromhexine Hydrochloride with R2=0.9992. The retention time of Terbutaline Sulphate was found to be around 2.1 min and for Bromhexine Hydrochloride it was found to be around 8.0 min. The precision, accuracy and robustness results were found to be satisfactory and within limits. The assay was found to be 96.7% (w/w) for Terbutaline sulphate and 97.7%(w/w) for Bromhexine Hydrochloride. Specificity experiments revealed the absence of interference from the mobile phase. The forced degradation studies like acidic, alkaline, oxidation and thermal degradation studies were performed and the degradation products were not interfering with the retention times of both the drugs. Thus, the developed method could be used in the routine analysis of the drugs in tablet dosage form.