ABSTRACT:
The objective of the study was to develop a simple, accurate, precise and rapid UV spectrophotometric, second order derivative, 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 second order derivative method involves the measurement of absorbance of one drug at zero crossing point of other; hence wavelengths 224 nm and 205 nm were selected for the estimation of bromhexine hydrochloride and salbutamol sulphate respectively. The linearity of the proposed method was found in the concentration range of 2 to 14 µg /ml (r2= 0.9992) for bromhexine hydrochloride and 2 to 16 µg /ml (r2= 0.9999) for salbutamol sulphate respectively. The percentage mean recovery was found to be 100.181 % for bromhexine hydrochloride and 100.203 % for salbutamol sulphate respectively. The method was also statistically validated for its linearity, accuracy and precision. Both intra and inter day variations showed less percentage (%) RSD values indicating high grade of precision of this method.