DEVELOPMENT AND VALIDATION OF A SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF SALBUTAMOL SULPHATE FROM PHARMACEUTICAL FORMULATIONS

  • G. R. GADEKAR Department of Pharmaceutics, Appasaheb Birnale College of Pharmacy, South-Shivaji Nagar, Sangli-Miraj Road, Sangli 416416, India
  • S. S PATIL Department of Pharmaceutics, Appasaheb Birnale College of Pharmacy, South-Shivaji Nagar, Sangli-Miraj Road, Sangli 416416, India
  • R. R. SHAH Department of Pharmaceutics, Appasaheb Birnale College of Pharmacy, South-Shivaji Nagar, Sangli-Miraj Road, Sangli 416416, India
  • D. S. GHODKE Department of Pharmaceutics, Appasaheb Birnale College of Pharmacy, South-Shivaji Nagar, Sangli-Miraj Road, Sangli 416416, India

Abstract

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.

Keywords: Salbutamol sulphate, UV Spectrophotometric method, Validation, Sorenson’s isotonic phosphate buffer pH 7

References

1. Indian Pharmacopiea. Delhi: Controller of publications; 1996. p. 668-70.
2. Healy A, Deirdre C, Owen C. Physicochemical and in vitro deposition properties of salbutamol sulphate/ipratropium bromide and salbutamol sulphate/excipients spray-dried mixtures for use in dry powder inhalers. Int J Pharm 2006;322:22-30.
3. http://www.apvma.gov.au [Last accessed on 10 Apr 2019]
4. ICH harmonized tripartite guideline: validation of analytical procedures: text and methodology Q2 (R1); 2005.
5. Sonawane S, Shirkhedkar A, Fursule Ravindra A, Surana S. Application of UV spectrophotometry and RP-HPLC for simultaneous determination of atorvastatin calcium and ezetimibe in the pharmaceutical dosage form. Eurasian J Anal Chem 2006;1:31-41.
6. Verma S, Alam O, Mullick P, Siddiqui N, Khan S. Validated, ultraviolet spectroscopy method for the dissolution study of mycophenolate mofetil immediate release 500 mg tablets. Nat Precedings Doi:10.1038/npre.2008.2250.
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G. R. GADEKAR, S. S PATIL, R. R. SHAH, and D. S. GHODKE. “DEVELOPMENT AND VALIDATION OF A SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF SALBUTAMOL SULPHATE FROM PHARMACEUTICAL FORMULATIONS”. International Journal of Current Pharmaceutical Research, Vol. 11, no. 5, Sept. 2019, pp. 72-75, doi:10.22159/ijcpr.2019v11i5.35707.
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