A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Bilastine in pure drug and tablet dosage form. The absorbance was measured at 226.2nm using Methanol as solvent system. It obeyed Beer’s law at the concentration range of 2-12µg/ml with coefficient of correlation (r2) of 0.9993. Limit of detection (LOD) was found to be 1.224µg/ml and Limit of quantitation (LOQ) was found to be 4.088µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.
Cite this article:
Afnaz Jahan, Mohamed Khaleel, Husnain Fathima. Estimation and Validation of Bilastine in Pharmaceutical Dosage Form and in Bulk Drug by Spectrophotometric Method. Asian Journal of Research in Chemistry. 2022; 15(4):279-3. doi: 10.52711/0974-4150.2022.00050
Afnaz Jahan, Mohamed Khaleel, Husnain Fathima. Estimation and Validation of Bilastine in Pharmaceutical Dosage Form and in Bulk Drug by Spectrophotometric Method. Asian Journal of Research in Chemistry. 2022; 15(4):279-3. doi: 10.52711/0974-4150.2022.00050 Available on: https://ajrconline.org/AbstractView.aspx?PID=2022-15-4-7
1. Wolthers O D. Bilastine : A new nonsedating oral H1 antihistamine for treatment of allergic rhinoconjuctivitis and urticaria. BMRI. 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. Drug Context. 2017; 6:212500.
3. Scaglione F. “Safety profile of bilastine : 2nd generation H1 antihistamines. ERMPS.2012;16(14):1999-2005.
4. 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.
5. Berrueta LA, Fernandez-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.
6. Amarendra CV, Anusha K, Muneer S. Method development and validation of new RP-HPLC method for the estimation of bilastine in pharmaceutical dosage form. WJPPS. 2017; 6(8):2297-2315.
7. Terzic J, Popovic I, Stajic A, Tumpa A, Jancic-Stojanovic B. Application of analytical quality by design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. JPBMA. 2016; 125:385-393.
8. ICH Q2 (R1). Validation of analytical procedures: text and methodology International Conference on Harmonization ICH, Geneva. 2005.
9. Mali DA, Manojkumar P. Estimation of Rantidine in Bulk and Formulation by First Order Derivative Area Under Curve UV-Spectrophotometry Methods. AJPA.2015; 5(2):61-66
10. PP Pardeshi, MV Gaware, BK Dhamak. Development and Validation of RP-HPLC Method for the Estimation of Bilsatine from bulk and Formulation. AJPA.2020; 10(2):109-111
11. S. Subramanya Raj Urs, Bindu M, Ramyashree D, Sowmya K N. Estimation of Cetirizine Hydrochloride in pharmaceutical preparation. AJPA.2020; 10(4)185-188
12. 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 antiallergic agent Bilastine. AJPA.2021; 11(2)57-62
13. Patel K K, Patel M A, Patel N C. A new simple RP-HPLC method development, Validation and Forced degradation studies of Bilastine.AJPA.2021; 11(3)183-187
14. Harikrishnan N, R Deepthi, V Manjusha, Vani S P, Jyothi A V M. Development and Validation of UV spectrophotometric methods of Loratadine in bulk and pharmaceutical formulation. AJPA.2010; 3(2)305-307
15. Harikrishnan N, Muralikrishna U, Vani S P, Jyothi AVM, Ranjithkumar V, Haribaskar. Development and Validation of UV spectrophotometric method of levocetirizine dihydrochloride in bulk and pharmaceutical formulation. AJPA. 2010; 3(3)539-541
16. Agarwal P N, Teli E N. A validated and simplified RP-HPLC method for Estimation of Ebastine from bulk drugs. AJPA.2011; 4(7)1164-1167
17. Sankar KSA, Baskar NG, Nagavalli D, Anandakumar K, Vetrichelvan T. Simultaneous Estimation of Montelukast Sodium and Levocetirizine hydrochloride from tablet dosage form. AJPA.2009; 2(4)743-745
18. Choudhari PV, Kale NA, Polshettiwar AS, Sutar S A, Patel M D, Kuchekar SB. Derivative and Absorption factor Spectrophotometric estimation of Montelukast Sodium and Levocetirizine dihydrochloride from pharmaceutical formulation. AJPA. 2011; 4(3)389-392