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, Nil
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 Folinâ€“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 Î»max was found to be 723nm for assay. Linearity was found in the concentration range of 10-50 Âµg/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.
Beckett AH, Stenlake JB. Practical pharmaceutical chemistry. 4th ed. New Delhi: CBS Publishers and Distributors; 1997. p. 275-81.
Kasture AV, Wadodkar SG, Mahadik KR, More HN. Pharmaceutical Analysis. 11th ed. Nirali Prakashan; 2004. p. 169-81.
Willard, Meritt, Dean, Settle. Instrumental methods of analysis. 7th ed. 1989. p. 118-72.
Sharma PP. Validation in pharmaceutical industry. 1st ed. 2007. p. 361-82.
Nash RA, Alfred HW. Pharmaceutical process validation. 3rd ed. 2008. p. 507-23.
British pharmacopeia; published by British Pharmacopoeia Commission Office; London; 2009. p. 5345-50.
Martis EA, Gangrade DM. Reverse phase isocratic HPLC method for simultaneous estimation of salbutamol sulphate and beclomethasone dipropionate in rotacaps formulation dosage forms. IJPPS 2011;3(1):64.
Dave HN, Mashru RC, Patel AK. Thin layer chromatographic method for the determination of ternary mixtures containing salbutamol sulphate,ambroxol hydrochloride and theophylline. IJPPS 2010;2(1):390-4.
Murtaza G, Ahmad M, Madni MA, Asghar MW. A new reverse phase HPLC method with fluorescent detection for the determination of salbutamol sulphate in human plasma. Bull Chem Soc Ethiop 2009;23(1):1-8.
Maithani M, Singh R. Development and validation of a stability-indicating HPLC method for the simultaneous determination of salbutamol sulphate and theophylline in pharmaceutical dosage forms. JABT 2011;2(1):1.
Venkata NT, Gopinath B, Bhaskar VV. Development and validation of UHPLC method for simultaneous estimation of sulbutamol sulphate and beclomethasone dipropionate. IJPBS 2012;2(1):254-68.
Patel PA, Dole MN, Shedpure PS, Sawant SD. Spectrophotometric simultaneous estimation of salbutamol sulphate and ambroxol in bulk and formulation. AJPCR 2011;4(3):6.