title: Impact of Ternary Solvent System in Stability-Indicating Assay Method of Bambuterol: Design of Experiments Approach.
abstract: High-performance liquid chromatography method for anti-asthmatic β2-agonist drug bambuterol, its process-related impurities and its major degradation products was developed and validated using quality by design concept. A 3(3) full factorial design was employed to study the effect of three independent factors, namely, ratio of organic modifiers in mobile phase, pH of the buffer and flow rate of the mobile phase. The responses considered were retention time of the last peak and resolution of poorly separated peaks (drug and PR-4 and drug and DP-3). The optimum conditions for separation were determined with the aid of design of experiments. The optimized ternary solvent composition was a mixture of 10 mM ammonium acetate buffer (pH 6.0), methanol and acetonitrile in the ratio of 90:5: 5 (v/v/v) in solvent reservoir A and 10:45:45 (v/v/v) in solvent reservoir B. The separation of the analytes was achieved by using a gradient method. The predictability criteria of the optimized method demonstrated good correlation between observed and predicted response. The method was validated for specificity, linearity, accuracy, precision and robustness in compliance with the International Conference on Harmonization guidelines Q2R1.
authors.affiliation: Department of Medicinal Chemistry, B. V. Patel PERD Centre, Ahmedabad, Gujarat 380054, India Registered Student (External), Institute of Science, Nirma University, Ahmedabad, Gujarat 380054, India.
authors.forename: A
authors.initials: A
authors.lastname: Abiramasundari
authors.affiliation: Department of Pharmaceutics, B. V. Patel PERD Centre, Ahmedabad, Gujarat 380054, India.
authors.forename: Amita
authors.initials: A
authors.lastname: Joshi
authors.affiliation: Department of Medicinal Chemistry, B. V. Patel PERD Centre, Ahmedabad, Gujarat 380054, India.
authors.forename: Rahul
authors.initials: R
authors.lastname: Joshi
authors.affiliation: Department of Medicinal Chemistry, B. V. Patel PERD Centre, Ahmedabad, Gujarat 380054, India.
authors.forename: Dhaivat
authors.initials: D
authors.lastname: Pandya
authors.affiliation: Department of Medicinal Chemistry, B. V. Patel PERD Centre, Ahmedabad, Gujarat 380054, India.
authors.forename: Jayesh
authors.initials: J
authors.lastname: Sharma
authors.affiliation: Department of Medicinal Chemistry, B. V. Patel PERD Centre, Ahmedabad, Gujarat 380054, India.
authors.forename: V
authors.initials: V
authors.lastname: Sudarsanam
authors.affiliation: Department of Medicinal Chemistry, B. V. Patel PERD Centre, Ahmedabad, Gujarat 380054, India kamalav@perdcentre.com.
authors.forename: Kamala K
authors.initials: KK
authors.lastname: Vasu
mesh_terms: D018927:Anti-Asthmatic Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D012997:Solvents / Q000032:analysis; D013726:Terbutaline / Q000031:analogs & derivatives* / Q000032:analysis
chemical_list: D018927:Anti-Asthmatic Agents; D012997:Solvents; D013726:Terbutaline; C047766:bambuterol