VALIDATED SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF MONTELUKAST SODIUM IN PURE AND DOSAGE FORMS USING N-BROMOSUCCINIMIDE AND DYES
Objective: Simple, sensitive, precise, reproducible and validated spectrophotometric methods have been developed for the quantification of montelukast sodium as leukotriene receptor antagonist drug, in pure and dosage forms (tablets).
Methods: The methods use N-bromosuccinimide (NBS) as an oxidant and three dyes, amaranth, methylene blue, and indigo carmine, as auxiliary reagents. The three methods are based on oxidation reaction of montelukast sodium with a known excess of N-bromosuccinimide (NBS) in acid medium, followed by determination of unreacted NBS by the reaction with a fixed amount of dyes, amaranth, methylene blue, and indigo carmine followed by the measurement of the absorbance at 520, 664 and 610 nm, respectively.
Results: Under the optimum conditions, linear relationships with good correlation coefficients (0.9993-0.9996) were found over the concentration ranges of 0.5-10, 1.0-12 and 0.5-8.0 µg/ml with a limit of detection (LOD) of 0.15, 0.3 and 0.14 µg/ml using amaranth, methylene blue, and indigo carmine methods, respectively. Intra-day and inter-day accuracy and precision of the methods have been evaluated. No interference was observed from the common tablet excipients.
Conclusion: The proposed methods were validated in accordance with ICH guidelines and successfully applied to the analysis of montelukast sodium in dosage forms (tablets). The reliability of the methods was further ascertained by performing recovery studies using the standard addition method. Statistical comparison of the results obtained by applying the proposed methods with those of the reported method by applying student’s t-test and F-test revealed good agreement.
2. Alsarra I, Khalil NY, Sultan M, Al-Ashban R, Belal F. Spectrofluorometric determination of montelukast in dosage forms and spiked human plasma. Pharmazie 2005;60:823-6.
3. Alsarra I, Al-Omar M, Gadkariem EA, Belal F. Voltammetric determination of montelukast sodium in dosage forms and human plasma. IL Farmaco 2005;60:563-7.
4. Flor S, Juan MH, Tripodi V, Lucangioli S. Development of an enantioselective capillary electrophoretic method for the simultaneous determination of montelukast enantiomeric and diastereoisomeric forms and its main degradation product. Electrophoresis 2016;37:2420-8.
5. Shakalisava Y, Regan F. Determination of montelukast sodium by capillary electrophoresis. J Sep Sci 2008;31:1137-43.
6. Mamatha J, Devanna N. RP-HPLC-PDA method for simultaneous quantification of montelukast, acebrophylline and desloratadine tablets. Asian J Chem 2018;30:1383-6.
7. Wang D, Zhou C, Cong R, Li Y, Wang X. Simultaneous determination of montelukast sodium S-enantiomer and A5 enantiomers in montelukast sodium bulk drug by normal-phase chiral HPLC. Indian J Pharm Sci 2017;79:139-48.
8. Padmavathi K, Subba Rao M. A new stability-indicating RP-HPLC method for the simultaneous determination of fexofenadine hydrochloride and montelukast in the combined dosage form. Der Pharm Lett 2015;7:301-7.
9. Rao MP, Srilakshmi M, Teja BR, Rao DN. Analytical method development and validation of levocetirizine hydrochloride and montelukast sodium in combined tablet dosage form by RP-HPLC. Res J Pharm Biol Chem Sci 2014;5:1010-21.
10. Jani A, Jasoliya J, Vansjalia D. Method development and validation of stability indicating RP-HPLC for simultaneous estimation of rupatadine fumarate and Montelukast sodium in combined tablet dosage form. Int J Pharmacy Pharm Sci 2014;6:229-33.
11. Redasani VK, Kothawade AR, Surana SJ. Stability indicating RP-HPLC method for simultaneous estimation of rupatadine fumarate and montelukast sodium in bulk and tablet dosage form. J Anal Chem 2014;69:384-9.
12. Saeed-Ul-Hassan S, Ather AUH, Ansari MT, Tariq I, Karim S. Determination of montelukast sodium in raw material and solid dosage form using reverse-phase HPLC. Asian J Chem 2013;25:7481-4.
13. Patnaik A, Panda SS, Sahoo S, Patro VJ. RP-HPLC method development and validation for the determination and stability indicative studies of montelukast in bulk and its pharmaceutical formulations. E J Chem 2012;9:35-42.
14. Kumar JVS, Swarupa PG, Vardhan SVM, Ramachandran D. Spectrophotometric determination of montelukast sodium in bulk and pharmaceutical formulations. Der Pharm Chem 2012;4:720-4.
15. Kumar JVS, Ramachandran D, Sushma K, Saradhi SV. Visible spectrophotometric methods for the estimation of montelukast sodium in bulk dosage forms and formulations. Orient J Chem 2010;26:293-6.
16. Srihari G, Setty KN, Reddy NR, Chakravarth IE. A simple spectrophotometric assay of montelukast in pharmaceutical formulations. J Chem Pharm Res 2011;3:23-7.
17. kumar JVS, Ramachandran D, Settaluri VS, Felice CS. Spectrophotometric methods for estimation of leukotriene receptor antagonists in bulk dosage forms. Rasayan J Chem 2010;3:166-71.
18. Adsule PV, Sisodiya K, Swami AG, Choudhari VP, Kuchekar BS. Development and validation of uv spectrophotometric methods for the estimation of montelukast sodium in bulk and pharmaceutical formulation. Int J Pharm Sci Rev Res 2012;12:106-8.
19. Arayne MS, Sultana N, Hussain F. Spectrophotometric method for the quantitative determination of montelukast in bulk, pharmaceutical formulations and human serum. J Anal Chem 2009;64:690-5.
20. Garg LK, Kumar BR, Sait SS, Krishnamurthy T. Determination of montelukast sodium in oral granules dosage forms by a simple and accurate UV spectrophotometric methods. Int J Pharm Sci Rev Res 2011;7:69-72.
21. Patil TN, Firke SD, Bari SB, Joshi NS, Bafna PS. Simultaneous estimation of ebastine and montelukast sodium in tablet dosage form by UV-spectrophotometry and first-order derivative. Indian Drugs 2013;50:47-52.
22. Berka A, Vulterin J, Zyka J. Newer redox titrants. 1st ed. Pergamon Press: London; 1965. p. 38.
23. Jeffery GH, Bassett J, Mendham J, Denney RC. Titrimetric analysis. In Vogel’s textbook of quantitative inorganic analysis. 5th Ed. ELBS: London; 1989. p. 286.
24. Kolthoff IM, Belcher R, Stenger VA, Matsuyama G. Volumetric analysis. III. Interscience Publishers, Inc, New York, USA; 1957. p. 504.
25. Jayanna BK, Devaraj TD, Nagendrappa G, Gowda N. Spectrophotometric estimation of aripiprazole in tablets. Indian J Pharm Sci 2016;78:694-6.
26. Amin AS, El Sheikh R, Mostafa MM, Gouda AA, Youssef EH. Spectrophotometric determination of pizotifen maleate in bulk drug and tablets using N-bromosuccinimide and three dyes. Int J Pharm Pharm Sci 2014;6:218-23.
27. Amin AS, Gouda AA, Youssef EH. Utility of N-bromosuccinimide as an environmental-friendly reagent for sensitive spectrophotometric determination of aripiprazole in tablets. Int J Pharm Pharm Sci 2014;6:247-53.
28. Hafez EM, El Sheikh R, Amin AS, Gouda AA. Simple spectrophotometric methods for the determination of two phosphodiesterase type 5-inhibitors in pure and tables dosage forms using N-bromosuccinimide as oxidant. Chem Sci Trans 2016;5:836-51.
29. El-Didamony AM, Saad MZ, Saleem NO. Spectrophotometric determination of some analgesic drugs in pharmaceutical formulations using N-bromosuccinimide as an oxidant. J Assoc Arab Univ Basic Appl Sci 2015;17:43-50.
30. Morrison RT, Boyd RN. Organic chemistry. 6th ed. New Jersey: Prentice-Hall; 2007. p. 390.
31. Ringbom A. Accuracy of colorimetric determination I and II. Z Anal Chem 1939;115:332-8.
32. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R 1), Complementary Guideline on Methodology, London; 2005.
33. Miller JN, Miller JC. Statistics and chemometrics for analytical chemistry. 5th ed. Prentice-Hall, England; 2005.
This work is licensed under a Creative Commons Attribution 4.0 International License.