Greens appraisal of validated stability indicating RP-HPLC method and forced degradation study for quantification of Ebastine in wastewater and dosage form

Imam, 2023, How environmentally friendly is the analytical process? A paradigm overview of ten greenness assessment metric approaches for analytical methods, Trends Environ Anal Chem, 38, 00202, 10.1016/j.teac.2023.e00202 Lotfy, 2021, Evaluation of assay and in-vitro dissolution profile of certain fixed-dose combination using green analytical method, Ann Pharm Fr, 79, 3, 10.1016/j.pharma.2020.07.007 Ragab, 2020, and stability-indicating RP-HPLC for the assay of dextromethorphan hydrobromide and menthol in their lozenges, Ann Pharm Fr, 78, 368, 10.1016/j.pharma.2020.04.006 Prajapati, 2022, DoE-based analytical quality risk management for enhanced AQbD approach to economical and eco-friendly RP-HPLC method for synchronous estimation of multiple FDC products of antihypertensive drugs, J Chromatogr Sci, 60, 786, 10.1093/chromsci/bmab070 British Pharmacopoeia Stationery Office, Medicines and Healthcare Products Regulatory Agency. 2023; London, Vol. II. Llupià, 2003, Comparative antiallergic effects of second-generation H1-antihistamines ebastine, cetirizine and loratadine in preclinical models, Arzneimittelforschung, 53, 93 Weiner, 1982, Sedation and antihistaminics, Arzneimittelforschung, 32, 1193 Malone, 1997, A cost of illness study of allergic rhinitis in the United States, J Allergy Clin Immunol, 99, 22 McCrory, 2003, Management of allergic rhinitis in the working-age population, Evid Rep Technol Assess (Summ), 67, 1 Bousquet, 1999, A 12-week, placebo-controlled study of the efficacy and safety of ebastine, 10 and 20 mg once daily, in the treatment of perennial allergic rhinitis, Allergy, 54, 562, 10.1034/j.1398-9995.1999.00984.x Sastre, 2008, Ebastine in allergic rhinitis and chronic idiopathic urticaria, Allergy, 63, 1, 10.1111/j.1398-9995.2008.01897.x Gehanno, 1996, Comparison of ebastine to cetirizine in seasonal allergic rhinitis in adults, Ann Allergy Asthma Immunol, 76, 507, 10.1016/S1081-1206(10)63269-3 Ratner, 2005, Meta-analysis of the efficacy of ebastine 20 mg compared to loratadine 10 mg and placebo in the symptomatic treatment of seasonal allergic rhinitis, Int Arch Allergy Immunol, 138, 312, 10.1159/000088869 Antonijoan, 2007, A comparison of ebastine 10 mg fast-dissolving tablet with oral desloratadine and placebo in inhibiting the cutaneous reaction to histamine in healthy adults, Clin Drug Investig, 27, 453, 10.2165/00044011-200727070-00002 Kalis, 1996, Double-blind multicentre comparative study of ebastine, terfenadine and placebo in the treatment of chronic idiopathic urticaria in adults, Drugs, 52, 30, 10.2165/00003495-199600521-00008 Hampel, 2004, A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ebastine (20 mg and 10 mg) to loratadine 10 mg once daily in the treatment of seasonal allergic rhinitis, J Investig Allergol Clin Immunol, 14, 56 Ortíz, 1993, Ebastine vs. terfenadine in allergic rhinitis, Rev Alerg, 40, 82 Frossard, 2000, Activity of ebastine (10 and 20 mg) and cetirizine at 24 hours of a steady state treatment in the skin of healthy volunteers, Fundam Clin Pharmacol, 14, 409, 10.1111/j.1472-8206.2000.tb00423.x Conde Hernandez, 1995, Comparison of azelastine nasal spray and oral ebastine in treating seasonal allergic rhinitis, Curr Med Res Opin, 13, 299, 10.1185/03007999509110490 Golightly, 2005, Second-generation antihistamines: actions and efficacy in the management of allergic disorders, Drugs, 65, 341, 10.2165/00003495-200565030-00004 Kosonen, 2009, The occurrence of antihistamines in sewage waters and in recipient rivers, Environ Sci Pollut Res Int, 16, 555, 10.1007/s11356-009-0144-2 Prabu, 2008, Determination of ebastine in pharmaceutical formulations by HPLC, Indian J Pharm Sci, 70, 406, 10.4103/0250-474X.43022 Patel, 2018, Stability indicating hplc method for antihistamine drug elastin along with degradation kinetic study, Int J Curr Adv Res, 7, 9372 Ibrahim, 2011, Validated stability indicating liquid chromatographic determination of ebastine in pharmaceuticals after pre column derivatization: application to tablets and content uniformity testing, Chem Cent J, 5, 24, 10.1186/1752-153X-5-24 Koduru, 2023, Stability-indicating RP-HPLC method applied to the quantification of anti-histaminic drug ebastine in its oral suspension dosage form, Drug Anal Res, 6, 8, 10.22456/2527-2616.128122 Mohamed, 2023, Validated stability indicating chromatographic method for determination of baricitinib and its degradation products in their tablet dosage form: implementation to content uniformity and in vitro dissolution studies, Ann Pharm Fr, 81, 267, 10.1016/j.pharma.2022.09.001 Hartman, 2011, Analytical Method Volume Intensity (AMVI): a green chemistry metric for HPLC methodology in the pharmaceutical industry, Green Chem, 13, 934, 10.1039/c0gc00524j Gałuszka, 2012, Analytical Eco-Scale for assessing the greenness of analytical procedures, TrAC, Trends Anal Chem, 37, 61, 10.1016/j.trac.2012.03.013 Wojnowski, 2022, AGREEprep-Analytical greenness metric for sample preparation, TrAC, 149, 1165 Guideline, 2005, Validation of analytical procedures: text and methodology, Q2 (R1), 1, 05