DEVELOPMENT AND VALIDATION OF A SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF SALBUTAMOL SULPHATE FROM PHARMACEUTICAL FORMULATIONS
Keywords:Salbutamol sulphate, UV Spectrophotometric method, Validation, Nil
Objective: The present study was undertaken to develop a rapid, simple, specific and economic ultraviolet (UV) spectrophotometric method for estimating the Salbutamol Sulphate (SS) in pharmaceutical formulations.
Methods: The analysis was performed at λ max 276 nm using Sorenson’s isotonic phosphate buffer pH 7 (SIPB pH 7) as blank/diluent. The method was validated by following the analytical performance parameters as suggested by International Conference on Harmonization (ICH) which included accuracy, precision, linearity.
Results: The drug follows the beer’s lambert’s law in the concentration range of 12.5-37.5μg/ml and exhibited good correlation coefficient (0.9997) and excellent mean recovery. Percentage RSD for precision and accuracy of the method was found to be less than 2%. This method was successfully applied for the determination of the Salbutamol Sulphate in commercial brands of Indian market and the results were in good agreement with the label claims. The developed method was suitable and specific to the analysis of Salbutamol Sulphate even in the presence of common excipients.
Conclusion: The obtained results proved that the validated method can be employed for the routine analysis of Salbutamol Sulphate in bulk as well as in the commercial formulations.
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