Spectrophotometric Estimation of Ambroxal hydrochloride in Bulk Drug and Pharmaceutical Dosage Form by Area Under Curve Method
V Rele Rajan
Abstract
V Rele Rajan
Abstract
A simple and precise UV-spectrophotometric method, area under curve [AUC], has been developed and validated for the estimation of ambroxal hydrochloride in bulk drug and its pharmaceutical formulation. Ambroxal hydrochloride was estimated by area under curve (AUC) method for the zero order spectrums in between 205 nm to 214 nm. Beer's law was obeyed in the concentration range of 1 to 10 μg/ml with coefficient of correlation value 0.9995. This method was tested and validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation, which was within the range of 0.2011% to 1.3330% 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.
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A simple and precise UV-spectrophotometric method, area under curve [AUC], has been developed and validated for the estimation of ambroxal hydrochloride in bulk drug and its pharmaceutical formulation. Ambroxal hydrochloride was estimated by area under curve (AUC) method for the zero order spectrums in between 205 nm to 214 nm. Beer's law was obeyed in the concentration range of 1 to 10 μg/ml with coefficient of correlation value 0.9995. This method was tested and validated for various parameters according to ICH guidelines. The precision expressed as relative standard deviation, which was within the range of 0.2011% to 1.3330% 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.
Key concepts: Relative standard deviation, Pharmaceutical formulation, Area under curve, Dosage form, Mathematics, Correlation coefficient, Standard deviation, Chromatography