Validation of ambroxal hydrochloride in bulk drug and pharmaceutical dosage form by third order derivative method in UV spectrophotometry

A simple and precise UV- spectrophotometric, third order derivative method has been developed and validated for the estimation of ambroxal hydrochloride in bulk drug and its pharmaceutical formulation. Ambroxal hydrochloride was estimated by third order derivative method at 215 nm. Beer’s law was obeyed in the concentration range of 1 to 10 μg / ml with coefficient of correlation value 0.9987. This method was tested and validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation, which was 2.7023 % for the above method. The proposed method was successfully applied for the determination of ambroxal hydrochloride in pharmaceutical formulation. Results of the analysis were validated statistically and were found to be satisfactory. The proposed method is simple, easy to apply, low-cost and require relatively inexpensive instruments.

Author(s): Rele Rajan V.

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