Simultaneous UV-spectrophotometric estimation of bromhexine hydrochloride and salbutamol sulphate by area under curve method in combined dosage form

Rajan V. Rele

Abstract

Simultaneous UV-spectrophotometric estimation of bromhexine hydrochloride and salbutamol sulphate by area under curve method in combined dosage form

The objective of the study was to develop a simple, accurate, precise and rapid UV spectrophotometric, area under curve (AUC), method for simultaneous estimation of bromhexine hydrochloride and salbutamol sulphate from combined dosage form. The validation was carried out by using ICH guidelines for the determination of bromhexine hydrochloride and salbutamol sulphate by using 0.1N hydrochloric acid as the solvent in pharmaceutical dosage form. The proposed area under curve method involves the measurement of area at selected analytical wavelength ranges and performing the analysis using “Cramer’s rule and Matrix method” .The two analytical wavelengths ranges were used i.e. 240-250 nm and 220-230 nm for estimation of bromhexine hydrochloride and salbutamol sulphate respectively. The linearity of the proposed method was found in the concentration range of 2- 14 µg /ml (r2= 0.9998) for bromhexine hydrochloride and salbutamol sulphate (r2=0.9999) respectively. The percentage mean recovery was found to be 100.083% for bromhexine hydrochloride and 100.111 % for salbutamol sulphate respectively. The method was statistically validated for its linearity, accuracy and precision as per ICH guidelines. Both intra and inter day variation showed less percentage (%) RSD values indicating high grade of precision of this method.