Author(s): Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati

Email(s): sraja61@gmail.com

DOI: 10.5958/0974-360X.2020.00507.7   

Address: Peethala Prathyusha, Raja Sundararajan*, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati
Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management, GITAM Institute of Pharmacy, Visakhapatnam, Andhra Pradesh-530045, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 6,     Year - 2020


ABSTRACT:
Bilastine is an anti-histaminic agent used for the treatment of allergic disorders such as rhinoconjunctivitis and urticaria. A simple, new RP-HPLC method was developed and validated for the determination of purity of Bilastine in bulk and pharmaceutical dosage form. A Shimadzu ModelCBM-20A/20 Alite HPLC system equipped with PDA detector was used. The chromatographic separation was achieved using Phenomenex Gemini C18 column (150 mm × 4.60 mm i.d. 5µm particle size) with formic acid: methanol as mobile phase in the ratio of 50:50 v/v. The flow rate was maintained at 0.8mL/min. The detection was done at 282 nm. The retention time was found to be 2.167min. Bilastine showed linearity in the concentration range of 5-100 µg/mL with linear regression equation y = 15283x + 1079.7 (R2 = 0.9999). The % RSD for precession and accuracy studies were found to be < 2%.The LOD and LOQ were found to be 0.08931 and 0.27063, respectively. The proposed method was observed to be simple, economical and was validated according to the ICH guidelines for linearity, precision, accuracy and stability.


Cite this article:
Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati. A new stability indicating RP-HPLC method for determination of Bilastine in bulk and pharmaceutical formulation. Research J. Pharm. and Tech 2020; 13(6): 2849-2853. doi: 10.5958/0974-360X.2020.00507.7

Cite(Electronic):
Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati. A new stability indicating RP-HPLC method for determination of Bilastine in bulk and pharmaceutical formulation. Research J. Pharm. and Tech 2020; 13(6): 2849-2853. doi: 10.5958/0974-360X.2020.00507.7   Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-6-57


REFERENCES:
1.    Wolthers OD. Bilastine: A new nonsedating Oral H1 antihistamine for treatment of allergic rhinoconjunctivitis and urticaria. Bio Med Research International. 2013; Article ID 626837.
2.    Leceta A, Sologuren A, Valiente R, Campo C, and Labeaga L. Bilastine in allergic rhinoconjunctivitis and urticaria: A practical approach to treatment decisions based on queries received by the medical information department. Drugs Context. 2017; 6: 212500.
3.    Rekha K, Aruna R, Mathappan R, Manasa Rekha M, Karthik S. Formulation and development of Bilastine tablets 20 mg. World Journal of Pharmaceutical Research. 2019; 8 (7): 2197-2224.
4.    Lucero ML, Gonzalo A, Mumford R, Betanzos M, Alejandro A. An overview of Bilastine metabolism during preclinical investigations. Drug and Chemical Toxicology. 2012; 35 (S1): 18–24.
5.    Erminia Ridolo, Marcello Montagni, Laura Bonzano, Cristoforo Incorvaia, and Giorgio Walter Canonica. Bilastine: new insight into antihistamine treatment. Clinical and Molecular Allergy. 2015; 13(1): 1.
6.    Lasseter KC, Sologuren A, La Noce A, Dilzer SC. Evaluation of the single-dose pharmacokinetics of Bilastine in subjects with various degrees of renal insufficiency. Clinical drug investigation. 2013; 33: 665–673
7.    Berrueta LA, Ferna´ndez-Armentia M, Bakkali M, Gonzalo A, Lucero ML. Matrix solid-phase dispersion technique for the determination of a new antiallergic drug, Bilastine, in rat faeces. Journal of Chromatography B. 2001; 760: 185–190.
8.    Radia Ouarezki , Saliha Guermouche1 and Moulay-Hassane Guermouche. Degradation kinetics of Bilastine determined by RP-HPLC method and identification of its degradation product in oxidative condition.  Chemical Papers. 2019.
9.    Amarendra CV , Anusha K, Muneer S. Method development and validation of new RP-HPLC method for the estimation of Bilastine in pharmaceutical dosage form. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 6 (8): 2297-2315.
10.    Terzić J, Popović I, Stajić A, Tumpa A, Jančić-Stojanović 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.
11.    Andressa TS, Gabriela R B, Isadora DM, Lisiane B, Donadel MM, Clésio SP. UV spectrophotometric method for quantitative determination of Bilastine using experimental design for robustness. Drug Analytical Research. 2017; 01(2): 38-43.
12.    Prathyusha P, Raja S. UV spectrophotometric method for determination of Bilastine in bulk and pharmaceutical formulation. Research Journal of  Pharmacy  and Technology  2020; 13(2): 933-938.
13.    ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
14.      ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization (2003).

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DOI: 10.5958/0974-360X 

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