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Simultaneous Spectrophotometric Estimation of Amoxicillin Trihydrate and Bromhexine Hydrochloride by Second Order Derivative Method in Combined Dosage Form

Rajan V. Rele and Prathamesh P. Tiwatane

The object of the study was to develop a simple, accurate, precise and rapid UV spectrophotometric, second order derivative method for validation of amoxicillin trihydrate and bromhexine hydrochloride from its combined pharmaceutical dosage form. The validation was carried out by using ICH guidelines for the determination of amoxicillin trihydrate and bromhexine hydrochloride by using 0.1N hydrochloric acid as the solvent in combined dosage form. The proposed second order derivative method involves the measurement of absorbance of one drug at zero crossing point of other; hence wavelengths 241.8 nm and 223.7 nm were selected for the estimation of amoxicillin trihydrate and bromhexine hydrochloride, respectively. The linearity of the proposed method was found in the concentration range of 10 to 100 µg/mL (r2 = 0.9998) for amoxicillin trihydrate and 1 to 14 µg/mL (r2 = 0.9997) for bromhexine hydrochloride, respectively. The percentage mean recovery was found to be 100.129 % for amoxicillin and 100.178 % for bromhexine hydrochloride, 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.