Author(s):
A. M. Beltagi, I. A. Lashin, W. A. Essa, A. A. Hathoot, M. Abdel Azzem
Email(s):
wafaa.ahmed1992@gmail.com
DOI:
10.52711/2231-5675.2021.00011 
Address:
A. M. Beltagi1, I. A. Lashin2, W. A. Essa2,3*, A. A. Hathoot3, M. Abdel Azzem3
1Department of Chemistry, Faculty of Science, Kafr El-Sheikh University, Kafr El-Sheikh, Egypt.
2Zeta Pharma for Pharmaceutical Industries, Sadat City, Menoufia Governorate, Egypt.
3Electrochemistry Laboratory, Chemistry Department, Faculty of Science, Menoufia University, Egypt.
*Corresponding Author
Published In:
Volume - 11,
Issue - 2,
Year - 2021
ABSTRACT:
A new, simple, accurate, and specific RP-HPLC stability method for determining bilastine was developed and validated. The proposed method was administered using C18 BDS Hypersil thermo column (4.6 × 250mm i.d), 5 µm particle size with a combination of potassium dihydrogen phosphate buffer pH 6.0: acetonitrile: methanol (50:25:25) as the mobile phase at a wavelength of 220nm. The retention time was 3.9 min for bilastine. The calibration plot was linear over the concentration range of 14.4–33.6µg/ml bilastine with LOD and LOQ of 0.04 and 0.11µg/ml, respectively. The technique was validated for linearity, sensitivity, accuracy, precision, and robustness. Percent recoveries were observed to be nearly 100%. The validated method was used for determining bilastine in Pharmabilast(R) tablets. The technique could be appropriate for routine evaluation at laboratories.
Cite this article:
A. M. Beltagi, I. A. Lashin, W. A. Essa, A. A. Hathoot, M. Abdel Azzem. Evolution and effectiveness of HPLC Technique for rapid estimation of an Antiallergenic agent Bilastine. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):57-2. doi: 10.52711/2231-5675.2021.00011
Cite(Electronic):
A. M. Beltagi, I. A. Lashin, W. A. Essa, A. A. Hathoot, M. Abdel Azzem. Evolution and effectiveness of HPLC Technique for rapid estimation of an Antiallergenic agent Bilastine. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):57-2. doi: 10.52711/2231-5675.2021.00011 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-2-1
REFERENCES:
1. Terzic, J.; Popovic, I.; Stajic, A.; Tumpa, A.; Jančic-Stojanovic, B., Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. Journal of Pharmaceutical and Biomedical Analysis 2016, 125, 385-393.
2. DA Silva, A. T., Brabo, G. R., Marques, I. D., Bajerski, L., Malesuik, M. D., and Paim, C. S., UV Spectrophotometric method for quantitative determination of Bilastine using experimental design for robustness. Drug Analytical Research 2017, 1, 38-43.
3. Scaglione, F., Safety profile of bilastine: 2nd generation H1-antihistamines. European Review for Medical and Pharmacological Sciences 2012, 16, 1999-2005.
4. Demonte, A.; Guanti, M.; Liberati, S.; Biffi, A.; Fernando, F.; Fainello, M.; Pepe, P., Bilastine safety in drivers who need antihistamines: new evidence from high-speed simulator driving test on allergic patients. J European review for medical pharmacological sciences 2018, 22, 820-828.
5. Wang, D. Y.; Wang, X. Y.; Lim-Jurado, M.; Prepageran, N.; Tantilipikorn, P., Treatment of allergic rhinitis and urticaria: a review of the newest antihistamine drug bilastine. Therapeutics and Clinical Risk Management 2016, 12, 585-597.
6. Graff, C.; Struijk, J. J.; Kanters, J. K.; Andersen, M. P.; Toft, E., Effects of Bilastine on T-wave Morphology and the QTc Interval. Clin Drug Investig 2012, 32, 339-351.
7. Lasseter, K. C.; Sologuren, A.; La Noce, A.; Dilzer, S. C., Evaluation of the single-dose pharmacokinetics of bilastine in subjects with various degrees of renal insufficiency. Clinical drug investigation 2013, 33, 665-673.
8. Berrueta, L.; Fernandez-Armentia, M.; Bakkali, A.; Gonzalo, A.; Lucero, M.; Orjales, A., Matrix solid-phase dispersion technique for the determination of a new antiallergic drug, bilastine, in rat faeces. J Journal of Chromatography B: Biomedical Sciences Applications 2001, 760 (1), 185-190.
9. Lucero, M. L.; Gonzalo, A.; Ganza, A.; Leal, N.; Soengas, I.; Ioja, E.; Gedey, S.; Jahic, M.; Bednarczyk, D. J. D., Interactions of bilastine, a new oral H1 antihistamine, with human transporter systems. Drug chemical toxicology 2012, 35, 8-17.
10. Bachert, C.; Kuna, P.; Zuberbier, T., Bilastine in allergic rhinoconjunctivitis and urticaria. Allergy 2010, 65, 1-13.
11. Motta, P. R.; Porto, D. d. S.; Martini, P. R. R.; Bajerski, L.; de Azeredo, J. B.; Paula, F. R.; Paim, C. S., Bilastine: quantitative determination by LC with fluorescence detection and structural elucidation of the degradation products using HRMS. Journal of AOAC International 2020.
12. Ouarezki, R.; Guermouche, S.; Guermouche, M.-H. J. C. P., Degradation kinetics of Bilastine determined by RP-HPLC method and identification of its degradation product in oxidative condition. Chemical Papers 2020, 74, 1133-1142.
13. Pardeshi, P. J.; Gaware, V. M.; Dhamak, K. B., Development and Validation of RP-HPLC Method for the Estimation of Bilastine from bulk and Formulation. Asian Journal of Pharmaceutical Analysis 2020, 10.
14. Guideline, I. H. T. In Validation of analytical procedures: text and methodology Q2 (R1), International Conference on Harmonization, Geneva, Switzerland, 2005; pp 11-12.
15. The United States Pharmacopeia, 38th ed., United States Pharmacopeial Convention: Rockville. 2015.
16. Chandana, O. S. S., Assay Method Development and Validation for Valsartan using high Performance liquid Chromatography. Asian Journal of Pharmaceutical Analysis 2020, 10.
17. Suneetha, A.; Mounika, V.; Sajid, S. M., Development and Validation of Stability indicating RP-HPLC Method for the simultaneous Estimation of Sitagliptin and Ertugliflozin in bulk and Tablet Dosage Forms. Asian Journal of Pharmaceutical Analysis 2020, 10.
18. Chowdhury, S. R.; Maleque, M.; Shihan, M. H., Development and validation of a simple RP-HPLC method for determination of caffeine in pharmaceutical dosage forms. J Asian Journal of Pharmaceutical Analysis 2012, 2, 1-4.
19. Thangabalan, B.; Salomi, M.; Sunitha, N.; Babu, S. M., Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical dosage form. J Asian Journal of Pharmaceutical Analysis 2013, 3, 119-123.
20. Sebaiy, M. M.; El-Shanawany, A. A.; El-Adl, S. M.; Abdel-Aziz, L. M.; Hashem, H. A., Rapid RP-HPLC method for simultaneous estimation of norfloxacin and tinidazole in tablet dosage form. J Asian Journal of Pharmaceutical Analysis 2011, 1, 79-84.
21. Pathi, P. J.; Raju, N. A.; Parvathalu, G., The Estimation of Sapropterin Dihydrochloride in Tablet dosage form by RP-HPLC. J Asian Journal of Pharmaceutical Analysis 2012, 2, 110-113.
22. Satyanarayana, L.; Naidu, S.; Rao, M. N.; Ayyanna, C.; Kumar, A. J. A. J. o. P. A., The Estimation of Raltigravir in Tablet dosage form by RP-HPLC. 2011, 1, 56-58.
23. Pathi, P. J.; Raju, N. A. J. A. J. o. P. A., The Estimation of Epalrestat in Tablet Dosage Form by RP-HPLC. 2012, 2, 49-51.
24. Revathi, R.; Naga, S. P. V.; Rao, M. K.; Ethiraj, T.; Rajarajan, S. J. A. J. o. P. A., Development and validation of RP-HPLC method for content analysis of Didanosine in dosage form. 2012, 2, 118-121.
25. Satyanarayana, L.; Naidu, S.; Rao, M. N.; Reddy, S. L. J. A. J. o. P. A., The Estimation of Nilotinib in Capsule dosage form by RP-HPLC. 2011, 1, 100-102.
26. Bhavya, B.; Nagaraju, P.; Mounika, V.; Priyadarshini, G. I. J. A. J. o. P. A., Stability indicating RP-HPLC method development and validation for simultaneous estimation of albendazole and ivermectin in pharmaceutical dosage form. 2017, 7.
27. WHO Technical Report Series. 2018, 1010.
28. Shah, P.; Pandya, T.; Gohel, M.; Thakkar, V., Development and Validation of HPLC method for simultaneous estimation of Rifampicin and Ofloxacin using experimental design. Journal of Taibah University for Science 2018, 13, 146-154.