QUANTIFICATION OF BILASTINE AND MONTELUKAST COMBINATION IN FORMULATIONS UTILIZING LIQUID CHROMATOGRAPHY: STABILITY STUDIES

Authors

  • KANCHARLA VIJAYALAKSHMI Quality Control Department, Divis laboratories limited, Hyderabad, India 508252
  • BETHAPUDI SAMUEL ANAND ANDREWS Department of Chemistry, Gitam Institute of Technology, GITAM University, Visakhapatnam, India 530045
  • BOLINENI NAGESWARA RAO Research and Development, Divis Laboratories Limited, Hyderabad, India 500018

DOI:

https://doi.org/10.22159/ijap.2021v13i6.41915

Keywords:

Bilastine, Montelukast, Tablet formulation, Stability indicating, Analysis

Abstract

Objective: We have developed a “stability indicating RP-HPLC” procedure for the Bilastine (BLS) and montelukast (MTL) analysis of tablets.

Methods: The quantification of BLS and MTL combination was implemented utilising a Waters column (C18, 5 μm, 250 mm and 4.6 mm).  Isocratic mobile phase had 60% volume KH2PO4 of 0.1M strength with pH 4.2 units and 40% volume methanol at a flow with 1.0 ml/min speed. UV detection at 232 nm was done to examine BLS and MTL. Stability experiments of BLS and MTL under distinctive environments of stress was also performed.

Results: The BLS and MTL were eluted at 1.810 min and 2.551 min, respectively. The responses were found to be linear for the concentration ranges of 10 - 30 µg/ml (BLS) and 5 - 15 µg/ml (MTL). Percent comparative standard deviance for precision was 0.331% (BLS) and 0.486% (MTL). Percent assay for accuracy was 98.96% (BLS) and 99.00% (MTL). The detection limit and quantitation limit measures for BLS were 0.018 µg/ml and 0.059 µg/ml, respectively while for MTL it was 0.024 µg/ml and 0.081 µg/ml, respectively. Robustness studies authorized that the method is robust with percent comparative standard deviance of a highest 1.950%.

Conclusion: The developed “stability indicating RP-HPLC” procedure for the BLS and MTL analysis is simple, sensitive, precise, specific and robust, making it appropriate to the assessment of BLS and MTL in a tablet formulation.

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References

Bousquet J, Khaltaev N, Cruz AA. Allergic rhinitis and its impact on asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA2LEN and AllerGen). Allergy 2008;63: 8-160.

Bousquet J, Cauwenberge PV, Khaltaev N. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001;108:S147–S334.

Corcóstegui R, Labeaga L, Innerárity A, Berisa A, Orjales A. Preclinical pharmacology of bilastine, a new selective histamine H 1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs in R & D 2005;6:371-84.

Corcóstegui R, Labeaga L, Innerárity A, Berisa A, Orjales A. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist. Drugs in R & D 2006;7:219–231.

Paggiaro P, Bacci E. Montelukast in asthma: a review of its efficacy and place in therapy. Ther Adv Chronic Dis 2011;2:47-58.

Baig S, Khan RA, Khan K, Rizvi N. Effectiveness and quality of life with montelukast in asthma - a double-blind randomized control trial. Pak J Med Sci 2019;35:731-36.

Hon KL, Leung TF, Leung AK. Clinical effectiveness and safety of montelukast in asthma. What are the conclusions from clinical trials and meta-analyses?. Drug Des Devel Ther 2014;8:839-50.

Raj RM, Sankar ASK, Vetrichelvan T. Analytical method development and validation for simultaneous estimation of bilastine and montelukast sodium by UV spectrophotometry. World J Pharm Pharm Sci 2020;10:680-87.

International Conference on Harmonization (ICH). Stability testing of new drug substances and products Q1A (R2). Geneva, Switzerland; 2003.

International Conference on Harmonization (ICH). Harmonized tripartite guideline validation of analytical procedures: Text and methodology Q2 (R1). Geneva: IFPMA, Switzerland; 2005.

Ravichandran V, Shalini S, Sundaram KM, Rajak H. Validation of analytical methods-strategies and importance. Int J Pharm Pharm Sci 2010;2:18-22

Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. Int J App Pharm 2018;10:8-15.

Panchumarthy R, Navya ChN, Pravallika D, Sri DN. A review on step-by-step analytical method validation. IOSR J Pharm 2015;5:7-19.

Marcello L, Dora M, Giuseppe C, Clinio L. Recent HPLC strategies to improve sensitivity and selectivity for the analysis of complex matrices. Instrum Sci Technol 2012;40:112-37.

Betz JM, Brown PN, Roman MC. Accuracy, precision, and reliability of chemical measurements in natural products research. Fitoterapia 2011;82:44-52.

Soumia B, Fatima H, Saïd B, Bouchaïb B, Souad T, Souad H, Ahmed B, Abdelmjid A. Statistical tools and approaches to validate analytical methods: methodology and practical examples. Int J Metrol Qual Eng 2017;8:1-10.

Rode DM, Rao NN. A review on development and validation of stability indicating HPLC methods for analysis of acidic drugs. Int J Curr Pharm Res 2019;11:22-33.

Rajasingam R, Sagineedu SR, Tan YH, Nalaiya J, Pichika MR. stress degradation studies and development of a validated RP-HPLC method for determination of tiagabine in presence of its degradation products. Int J Pharm Pharm Sci 2016;8:230-6.

Rao PVL, Rao A, Svum P. Development and validation of new stability indicating reversed-phase high-performance liquid chromatography method for simultaneous determination of metformin hydrochloride and ertugliflozin in bulk and pharmaceutical dosage form. Asian J Pharm Clin Res 2019;12:235-40.

Sergio LCF, Adriana OC, Thaise da SB, Ariana MDSL, Laiana OBS, Walter NLS. Robustness evaluation in analytical methods optimized using experimental designs. Microchemical Journal 2017;131:163-9.

Epshtein NA. System suitability requirements for liquid chromatography methods: controlled parameters and their recommended values (Review). Pharm Chem J 2020;54:518–25.

Published

06-09-2021

How to Cite

VIJAYALAKSHMI, K., ANAND ANDREWS, B. S., & NAGESWARA RAO, B. (2021). QUANTIFICATION OF BILASTINE AND MONTELUKAST COMBINATION IN FORMULATIONS UTILIZING LIQUID CHROMATOGRAPHY: STABILITY STUDIES. International Journal of Applied Pharmaceutics, 13(6). https://doi.org/10.22159/ijap.2021v13i6.41915

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