DEVELOPMENT OF NEW ANALYTICAL METHOD AND ITS VALIDATION FOR THE DETERMINATION OF SALBUTAMOL SULPHATE IN BULK AND MARKETED FORMULATIONS
Keywords:
Salbutamol Sulphate, Colorimetric method, Nil, Validation, NilAbstract
Objective: The present study aims to develop a simple, sensitive, specific, and validated colorimetric method for the quantitative estimation of Salbutamol Sulphate in bulk and pharmaceutical dosage form.
Method: A simple colorimetric method for the determination of Salbutamol Sulphate in pure as well as in its dosage form has been developed. The method is based on formation of a blue coloured chromogen by the interaction of Salbutamol Sulphate with Folin–Ciocalteu reagent under basic condition and the maximum absorbance of the developed chromogen was found. The developed method is validated in terms of Linearity, Accuracy, Precision, Limit of Detection, Limit of Quantitation, as per ICH Guidelines.
Results: The λmax was found to be 723nm for assay. Linearity was found in the concentration range of 10-50 µg/ml respectively with a correlation coefficient of 0.9979. The regression equation was found as y=bx+a: 0.0199x+0.0208.
Conclusion: The proposed method makes use of simple reagent, which an ordinary analytical laboratory can afford. The method was found to be simple, precise, economic and less time consuming. The method has been statistically evaluated and results obtained are accurate, precise and insensitive and free from the interferences of other additives present in the formulation.
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