Rp-HPLC methods for the simultaneous determination of Salbutamol and Bromhexine in syrup

Abstract

The purpose of this study is to develop a fast, accurate, simple Rp-HPLC method for the simultaneous analysis of Salbutamol and Bromhexine in drug syrup. Chromatographic separation was performed on the Phenomenex Genimi NX-C18 column (250mm × 4.6mm, 5µm). Isocratic elution with a mixture of methanol - orthophosphoric acid 0.07% (59:41, v/v). The flow rate was maintained at 0.9ml/min, and the column temperature was 25°C. The detection wavelength is 225nm. The method has been validated according to the guidelines and met the requirements of ICH Q2R1. The research results show good linearity (R2 > 0.999), the linear range determined are from 4-24μg/ml for Salbutamol and 8-48μg/ml for Bromhexine. The regression equation was y = 16,503x +0,0383 for Salbutamol and y = 17,084x + 0,624 for Bromhexine, respectively; the precision and accuracy of the method (RSD < 2%, average recovery value of Salbutamol is 99.2-99.5% and Bromhexine is 99.5-99.8%.