Abstract

Simultaneous determination of amoxicillin trihydrate and bromhexine hydrochloride in pharmaceutical dosage by reverse phase high performance liquid chromatography

Author(s): Rajan V. Rele and Rajesh N. Mali

Rapid and accurate high performance liquid chromatography method is described for simultaneous determination of amoxicillin trihydrate and bromhexine hydrochloride from the combine formulation i.e. capsules. The separation of two drugs was achieved on a ZORBAX Eclips XDB C18 (150 x 4.6 mm i.d.) 5 μ particle size. The mobile phase consisted of methanol, water and triethylamine in the ratio of 50: 50: 0.1(v/v). The pH was adjusted to 3.0 with orthophosphoric acid. The detection was carried out at wavelength 248 nm. The ZORBAX Eclips XDB column showed the most favorable chromatographic parameters for analysis. The method was validated for system suitability, linearity, accuracy, precision, robustness and stability of solution. The linear range for amoxicillin trihydrate and bromhexine hydrochloride was 625 - 1875 μg / ml and 20 - 60 μg / ml respectively. The method has been successfully used to analyse commercial solid dosage i.e. capsules containing 250 mg of amoxicillin trihydrate and 8 mg. of bromhexine hydrochloride with good recoveries.

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