Abstract
A precise, accurate and sensitive high-performance thin-layer chromatographic method has been developed and validated for the simultaneous determination of montelukast and bilastine in a tablet dosage form which is used in the treatment of allergic rhinitis. The proposed method used aluminum plates pre-coated with silica gel 60F254 as the stationary phase and acetonitrile–ethyl acetate–ammonia (4:6:0.1, V/V) as the mobile phase for separation purpose. Densitometric detection was carried out at 282 nm in ultraviolet. Compact spots of montelukast and bilastine were obtained at RF 0.53 and 0.27, respectively. Linear responses were shown by the detector over the range of 100‒500 ng/band for montelukast and 200‒1000 ng/band for bilastine. The proposed method was validated as per the International Council for Harmonisation guidelines. The method was applied for the estimation of both drugs in tablet formulation and their synthetic mixture.
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References
Pubchem (2020) Montelukast. https://pubchem.ncbi.nlm.nih.gov/compound/Montelukast. Accessed: 25 August 2020.
Scott JP, Peters-Golden M (2013) Antileukotriene agents for the treatment of lung disease. Am J Respir Crit Care Med 188:538–544
Bronsky EA, Kemp JP, Zhang JM, Guerriro D, Reiss TF (1997) Dose-related protection of exercise bronchoconstriction by montelukast, a cysteinyl leukotriene-receptor antagonist, at the end of a once-daily dosing interval. Clin Pharmacol Ther 62:556–561. https://doi.org/10.1016/S0009-9236(97)90051-5
Pubchem (2020) Bilastine. https://pubchem.ncbi.nlm.nih.gov/compound/Bilastine. Accessed: 25 August 2020.
Ridolo E, Montagni M, Bonzano L, Incorvaia C, Canonica GW (2015) Bilastine: new insight into antihistamine treatment. Clin Mol Allergy 13:1–6. https://doi.org/10.1186/s12948-015-0008-x
Carter NJ (2012) Bilastine. Drugs 72:1257–1269
ClinicalTrials.gov (2020) Efficacy of Co-administration of Bilastine and Montelukast in Patients with SARC and Asthma. https://clinicaltrials.gov/ct2/show/NCT02761252. Accessed: September 2020.
Andressa TS, Gabriela RB (2017) UV Spectrophotometric method for quantitative determination of bilastine using experimental design for robustness. Drug Anal Res 01:38–43. https://doi.org/10.22456/2527-2616.79221
Peethala P, Raja S (2020) UV spectrophotometric method for determination of bilastine in bulk and pharmaceutical formulation. Res J Pharm Tech 13:933–938. https://doi.org/10.5958/0974-360X.2020.00176.6
Chowdary VA, Kota A, Syed M (2017) Method development and validation of new RP-HPLC method for the estimation of bilastine in pharmaceutical dosage form. World J Pharm Sci 6:2297–2315. https://doi.org/10.5958/0974-360X.2020.00507.7
Ouarezki R, Guermouche S, Guermouche MH (2020) Degradation kinetics of bilastine determined by RP-HPLC method and identification of its degradation product in oxidative condition. Chem Pap 74:1133–1142. https://doi.org/10.1007/s11696-019-00956-x
Katta R, Murty NNVVSSN, Srinivas R, Rao GN (2020) Stability indicating method development and validation for the determination of bilastine and its impurities by UPLC method. Int J Pharm Sci Res 11:1312–1321. https://doi.org/10.13040/IJPSR.0975-8232.11(3).1312-21
Kurra P, Puttagunta B (2012) Validated UV spectroscopic method for estimation of montelukast sodium from bulk and tablet formulations. Int J Med Sci 1:104–111. https://doi.org/10.13040/IJPSR.0975-8232.6(11).4728-31
Selvadurai M, Kaur N, Parasuraman S, Kumar J, Palanimuthu VR, Venugopal V, Muralidharan S, Qi JL (2016) Newly developed and validated method of montelukast sodium estimation in tablet dosage form by ultraviolet spectroscopy and reverse phase-high performance liquid chromatography. PTB Reports 2:27–30
Chaudhary M, Kumar P, Thapliyal D (2018) Analytical method development and validation for determination of montelukast by UV–spectroscopy in API & In Pharmaceutical dosage forms. Int J Pharm Biol Sci 8:482–487
Singh RM, Saini PK, Mathur SC, Singh GN, Lal B (2010) Development and validation of a RP-HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form. Indian J Pharm Sci 72:235–237. 10.4103%2F0250-474X.65023
Raju KN, Swamy TG, Rao AL (2011) Development and validation of RP-HPLC method for the determination of montelukast sodium in bulk and in pharmaceutical formulation. Int J Pharm Chem Biol Sci 1:12–16
Smith GA, Rawls CM, Kunka RL (2004) An automated method for the determination of montelukast in human plasma using dual-column HPLC analysis and peak height summation of the parent compound and its photodegradation product. Pharm Res 21:1539–1544. https://doi.org/10.1023/b:pham.0000041445.76931.27
Sane RT, Menezes A, Moghe A, Mote M (2004) HPTLC determination of montelukast sodium in bulk drug and in pharmaceutical preparations. J Planar Chromatogr 17:75–78. https://doi.org/10.1556/JPC.17.2004.1.17
Hamad M (2020) Development and validation of montelukast with grape/liquorice juices and its application to pharmacokinetic studies by LC/MS. Indones J Pharm 31:1–5. https://doi.org/10.22146/ijp.590
Sankar ASK, Vetrichelvan T (2021) Analytical method development and validation for simultaneous estimation of bilastine and montelukast sodium by UV spectrophotometry. World J Pharm Pharm Sci 10:680–687. https://doi.org/10.17605/OSF.IO/2KNDM
Gupta TVL (2021) Stability indicating isocratic HPLC approach to quantify montelukast and bilastine mix in bulk and formulation of tablets. Indian Drugs (accepted for publication: 24 Jan 2021)
Indian Pharmacopoeia (2018) Government of India, Ministry of Health & Family Welfare, Indian Pharmacopoeia Commission, Vol. II, Ghaziabad, pp 2628–2633
United States Pharmacopeia (2019) National Formulary (USP 43 NF 38), the United States Pharmacopeial Convention 12601, Vol 2, Rockville, MD, pp 2778
Japanese Pharmacopeia (2016) Volume XVII, The Ministry of Health, Labour and Welfare, Tokyo, pp 1264–1271
International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedure: Text and Methodology, ICH Q2 (R1), Geneva, 2005
Swapna K, Aparna C, Srinivas P (2015) Formulation and evaluation of montelukast sodium and levocetirizine dihydrochloride sublingual tablets. Asian J Pharm Clin Res 8:171–175
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The authors are thankful to Principal, Babaria Institute of Pharmacy, for providing facility for performing the analytical work.
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Shah, D.A., Patel, P.A. & Chhalotiya, U. Thin-layer chromatographic‒densitometric method of analysis for the estimation of montelukast and bilastine in combination. JPC-J Planar Chromat 34, 289–295 (2021). https://doi.org/10.1007/s00764-021-00120-w
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DOI: https://doi.org/10.1007/s00764-021-00120-w