DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHODS FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULPHATE AND DOXOPHYLLINE IN COMBINED SOLID DOSAGE FORM

  • Anjoo Kamboj Chandigarh College of Pharmacy, Landran, Mohali, Punjab, India.
  • Pawan Sidana Chandigarh College of Pharmacy, Landran, Mohali (Punjab)
  • Upendra K. Jain Chandigarh College of Pharmacy, Landran, Mohali (Punjab)

Abstract

Objective: Salbutamol sulphate (SBS) and doxophylline (DOX) was used for the treatment of asthma and bronchitis. In the present study, two simple, accurate, precise, reproducible and economical UV-spectroscopic methods (A and B) for simultaneous estimation of SBS and DOX in tablet dosage form have been developed.

Methods: In the present study the simultaneous estimation of SBS and DOX was carried out by two methods. Method A employs solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 272 nm and 276 nm which are the ðœ†max values of SBS and DOX respectively in phosphate buffer (pH 7.4). Method B is based on the principle of Q-Analysis where in, absorbance was measured at 225 nm (iso-absorptive point, ðœ†1) and 276 nm (ðœ†max of DOX, ðœ†2) in phosphate buffer (pH 7.4).

Results: Both SBS and DOX shows linearity at all the selected wavelengths and obeys beer’s law in the concentration range of between 0.2-1.6ðœ‡g/ml and 0.1-3.5μg/ml at 276 nm; 0.2-1.6 µg/ml and 0.1-4.5 µg/ml at 272 nm and 0.2-2.0µg/ml and 0.2-3.5μg/ml at iso-absorptive point 225 nm. Recovery studies for SBS and DOX were performed and the percentage recovery for both the drugs was obtained in the range of 97.45-98.63% (Method A) and 97.49–98.87 % (Method B) confirming the accuracy of the proposed method.

Conclusion: Both the methods showed good reproducibility and recovery with % RSD less than 2. Statistical validation of the data shows that the proposed methods can be successfully applied for the routine analysis of drugs in commercial tablets. Hence, it could be used in the analysis of laboratory samples and marketed formulations containing these two drugs in combined dosage form without the interference of common excipients.

Keywords: Simultaneous equation method, Q-absorbance ratio method, Salbutamol, Doxophylline

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References

1. Barnes PJ, Page CP. Pharmacology and therapeutics of asthma and COPD. Springer-Verlag Berlin Heidelberg, Germany; 2004. p. 15.
2. Robert AS. Chronic obstructive pulmonary disease, Blackwell Publishing House, UK; 2007. p. 680.
3. Brum PC, Rolim NPL, Bacurau AVN, Medeiros A. Rhizophores in rhizophora mangle L: an alternative interpretation of so-called “aerial roots. Ann Brazilian Acad Sci 2006;78:485-503.
4. Villani F, De Maria P, Ronchi E, Galimberti M. Oral doxofylline in patients with chronic obstructive pulmonary disease. Int J Clin Pharmacol Ther 1997;35:107-11.
5. Cirillo R, Barone D, Franzone JS. Doxofylline, an antiasthmatic drug lacking affinity for adenosine receptors. Arch Int Pharmacodyn Ther 1988;295:221-37.
6. Dini FL, Cogo R. Doxofylline: a new generation xanthine bronchodilator devoid of major cardiovascular adverse effects. J Curr Med Res Opin 2001;16:258-68.
7. European Pharmacopoeia. EDQM, Strasbourg; 2005. p. 3611.
8. The British Pharmacopoea. Her Majesty’s Stationery Office, London; 1998. p. 1151–2.
9. Indian Pharmacopoeia. The Controller of Publications, Ministry of Health and Family Welfare, Government of India, New Delhi; 1996. p. 670–3.
10. Bernal TL, del-Nozal MJ, Velasco H, Toribio L. HPLC versus SFC for the determination of salbutamol sulphate and its impurities in pharmaceuticals. J Liq Chromatogr Rel Technol 1996;19:1579–89.
11. Ray S, Bandopadhyay A. Reversed phase high performance liquid chromatographic determination of salbutamol sulphate in pharmaceutical formulations. Indian Drugs 1990;27:313–6.
12. Talwar N, Singhai AK, Shakya AK, Saraf S, Jain NK. Difference spectrophotometric determination of salbutamol sulphate in tablets. Indian Drugs 1991;28:244–5.
13. Habib IHI, Hassouna MEM, Zaki GA. Simultaneous spectrophotometric determination of salbutamol and bromhexin in tablets. Farmaco 2005;60:249–54.
14. Reddy MN, Sankar DG, Rao GD, Sreedhar K. Spectrophotometric determination of salbutamol and terbutaline. East Pharm 1991;34:127–8.
15. Basu M, Pathak B. Estimation of salbutamol sulphate in pharmaceutical formulations. Indian Drugs 1990;28:109–10.
16. Geetha N, Baggi TR. Improved spectrophotometric method for the determination of salbutamol sulphate with 3-methyl benzothiazolin-2-one hydrazone. Microchem J 1989;39:137–44.
17. Naidu NV, Naidu DV, Rajeshwari CV, Naidu PR. Simple spectrophotometric determination of salbutamol sulphate in pharmaceutical formulations. Acta Chim Hung 1989;126:821–4.
18. Vishwanth KK, Rao AS, Shivaramakrishnan MV. Colorimetric determination of salbutamol in pharmaceutical preparations. Indian Drugs 1989;26:516–8.
19. Patel RB, Patel AS, Pallavi U. Spectrophotometric determination of salbutamol sulphate and its combination in pharmaceutical dosage forms. Indian Drugs 1987;24:298–302.
20. ICH-International Conference on Harmonization. Topic Q2B, Validation of Analytical Methods: Methodology. The Third International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Yokohama-Japan; 2005;8:71-6.
21. Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry. 4th ed. part one, published by CBS Publishers and Distributors, New Delhi, India; 2005. p. 133-6.
22. Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry. 4th ed. part two, published by CBS Publishers and Distributors, New Delhi, India; 2005. p. 275-306.
23. Mendham J, Denney RC, Barnes JD, Thomas MJK. Vogel’s Quantitative Chemical Analysis. 6th ed. Published by pearson Education, Delhi, India; 2004. p. 630-6.
24. Kamboj A, Matta Y, Kohar V. Development and validation of ultra violet spectrophotometric method for determination of acid dissociation constant of tramadol hydrochloride. W J Pharm Res 2016;5:582-99.
25. Patel PA, Dole MN, Shedpure PS, Sawant SD. Spectrophotometric simultaneous estimation of salbutamol and ambroxol in bulk and formulation. Asian J Pharm Clin Res 2011;4:42-5.
26. Kant R, Bodia R, Kapoor G, Bhutani R. Development and validation of novel spectrophotometric methods for simultaneous estimation of pioglitazon and metformin in bulk and fixed dosage forms by area under curve and dual wavelength mode. Inter J Appl Pharm 2016;8:48-53.
27. https://pubchem.ncbi.nlm.nih.gov/image/fl.html?cid=39859. [Last accessed on 10 Jul 2016]
28. https://pubchem.ncbi.nlm.nih.gov/image/fl.html?cid=50942. [Last accessed on 10 Jul 2016]
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Kamboj, A., P. Sidana, and U. K. Jain. “DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHODS FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULPHATE AND DOXOPHYLLINE IN COMBINED SOLID DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 9, no. 6, June 2017, pp. 117-22, doi:10.22159/ijpps.2017v9i6.14938.
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