Development and Validation of High Performance LCMS Methods for Estimation of Ebastine and Carebastine in Human Plasma
Abstract
A simple and specific method for simultaneous determination of Ebastine and Carebastine by liquid chromatography-tandem mass spectrometry operated in positive ionization mode was developed and validated. The column used was a BDS Hypersil C18, 50 mm × 4.6 mm, 5µm with a flow rate of 0.6 mL/min, without splitter for the chromatographic analysis with flow rate of 0.6 mL/min. Solid phase extraction method was applied. Mass parameters, 496.2/261.0 and 672.2/479.3/261.2 were chosen for analysis. Linearity was established in human plasma covering the concentration range of 0.051 ng/mL to 31.099 ng/mL for Ebastine and 1.013 ng/mL to 1005.451 ng/mL for Carebastine using (Ebastine D6 & Carebastine D6) as internal standards. Different parameters such as linearity, range, precision, accuracy, ruggedness and robustness, limit of detection (LOD) and limit of quantification (LOQ) were used for full validation of the method. The results were found to be acceptable as per the guidelines of International Conference on Harmonization (ICH). The method found to be novel, rapid, linear, precise, accurate, robust and rugged and can be successfully applied for the routine analysis of Ebastine and Carebastine with more sensitivity and covers wider range of quantitation. The method also found to be useful and economical.
Keywords:
Ebastine and Carebastine, LCMS, Validation, Solid phase extraction, ICHDOI
https://doi.org/10.25004/IJPSDR.2018.100601References
pubchem.ncbi.nlm.nih.gov/compound/ebastine#section=2D-Structure
Savsani JJ, Goti PP, Patel PB. Development and validation of simultaneous equation method for estimation of ebastine and montelukast sodium in combined tablet dosage form. Der Pharmacia Sinica. 2012; 3(6): 690-698.
Kang W, Liu KH, Ryu JY, Shin JG. Simultaneous determination of Ebastine and its three metabolites in plasma using liquid Chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004; 813(1-2): 75-80.
Soni LK, Narsinghani T, Charu Saxena C. Development and validation of UVSpectrophotometric assay protocol for simultaneous estimation of Ebastine and Phenylephrine Hydrochloride in tablet dosage form using simultaneous equation method. International Journal of ChemTech Research. 2011; 3(4): 1918-1925.
El-Kommos ME, El-Gizawy SM, Atia NN, Hosny NM. Analysis for commonly prescribed non-sedating antihistamines. Analytical Chemistry Research. 2015; 3: 1-12.
Peyri J, Vidal J, Marrón J, et al (1991). Ebastine in chronic urticaria: a double-blind placebo Controlled study. J Dermatol Treat. 1991; 2(2):51-53.
Hajare RA, Tated AG, Gadbail PA, Ghan FA, Kayal SD. Method Development and Validation for Simultaneous Determination Ebastine and Phenylephrine Hydrochoride in Tablet Formulation by RP-HPLC. IJPRD. 2011; 3(7): 214-220.
Wagh RS, Hajare RA, Tated A, Chandewar AV. Absorption Correction Method and Simultaneous Equation Method for the Simultaneous Estimation of Ebastine and Phenylephrine Hydrochloride in Bulk and In-combined Tablet Dosage Form. IJRPC. 2011; 1(4):812-819.
Salvà M, Carreño B, Pintos M, et al. Phase I. single dose, open label, randomized, Crossover bioequivalence studies of Ebastine 10 mg and 20 mg regular tablets vs. 10 and 20 mg fast dissolving tablets in healthy male volunteers. JIACI. 2004; 14(4): S5.
Shantha A. Spectrophotometric methods for the Determination of Ebastine in tablets. Indian Drugs. 2003; 40(10):149-151.
Feng S, Jiang J, Wang P, Liu D, Hu P. Simultaneous Determination of Ebastine and Its Active Metabolite (Carebastine) in Human Plasma Using LC–MS–MS. Chromatographia. 2009; 70:1417
Shirwaikar A. Determination of Ebastine in pharmaceutical Formulations by HPLC. Indian Journal of Pharmaceutical Sciences. 2008; 70(3):403-406
September 2013; Draft Guidance for Industry; Bioanalytical Method Validation U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Veterinary Medicine (CVM); Bio pharmaceutics; Revision 1
Sreedhar NY, Sreenivasulu A, Sunil Kumar M, Nagaraju M. Electrochemical Determination of Ebastine in Tablet Dosage Forms at Hanging Mercury Drop Electrode. International Journal of PharmTech Research. 2012; 4(3):1303-1308.
Tagawa M, Kano M, Okamura N, et al. Neuroimaging of histamine H1-receptor occupancy in human brain by positron emission tomography (PET): a comparative study of ebastine, a second-generation antihistamine, and (+)-clorphrniramine, a classical antihistamine. British Journal of Clinical Pharmacology. 2001; 52:501-509.
Vaidhyalingam V. Charge Transfer Complex method for the estimation of Ebastine in tablets. Indian Drugs. 2003; 40(7):390-392
Vaidhyalingam V. Development and Validation of HPLC and HPTLC methods for the Quantification of Ebastine in tablets. Indian Drugs.2004; 41(3):149-151.
Van Cauwenberge P, de Belder T, Sys L. A review of the second-generation antihistamine ebastine for the treatment of allergic disorders. Expert opinion on pharmacotherapy. 2004; 5(8):1807-13.
Published
Abstract Display: 616 
PDF Downloads: 1048 
