title: Development and Validation of a Stability-Indicating Liquid Chromatographic Method for Estimating Olmesartan Medoxomil Using Quality by Design.
abstract: The current studies entail systematic quality by design (QbD)-based development of a simple, rapid, sensitive and cost-effective stability-indicating method for the estimation of olmesartan medoxomil. Quality target method profile was defined and critical analytical attributes (CAAs) for the reverse-phase liquid chromatography method earmarked. Chromatographic separation accomplished on a C18 column using acetonitrile and water (containing 0.1% orthophosphoric acid, pH 3.5) in 40 : 60 (v/v) as mobile phase at a flow rate of 1.0 mL/min with UV detection at 243 nm. Risk assessment studies and screening studies facilitated comprehensive understanding of the factors affecting CAAs. The mobile phase ratio and flow rate were identified as critical method parameters (CMPs) and were systematically optimized using face-centered cubic design, evaluating for CAAs, namely peak area, retention time, theoretical plates and peak tailing. Statistical modelization was accomplished followed by response surface analysis for comprehending plausible interaction(s) among CMPs. Search for optimum solution was conducted through numerical and graphical optimization for demarcating the design space. Analytical method validation and subsequent forced degradation studies corroborated the method to be highly efficient for routine analysis of drug and its degradation products. The studies successfully demonstrate the utility of QbD approach for developing the highly sensitive liquid chromatographic method with enhanced method performance.
authors.affiliation: University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, UGC Center for Excellence in Nano Applications, Panjab University, Chandigarh 160 014, India.
authors.forename: Sarwar
authors.initials: S
authors.lastname: Beg
authors.affiliation: University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, UGC Center for Excellence in Nano Applications, Panjab University, Chandigarh 160 014, India Formulation Research and Tech Transfer, IPCA Laboratories Limited, Kadhivali (W), Mumbai 400 067, India.
authors.forename: Gajanand
authors.initials: G
authors.lastname: Sharma
authors.affiliation: University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, UGC Center for Excellence in Nano Applications, Panjab University, Chandigarh 160 014, India.
authors.forename: O P
authors.initials: OP
authors.lastname: Katare
authors.affiliation: UGC-Centre of Excellence in Applications of Nanomaterials, Nanoparticles & Nanocomposites (Biomedical Sciences), Panjab University, Chandigarh 160 014, India.
authors.forename: Shikha
authors.initials: S
authors.lastname: Lohan
authors.affiliation: University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies, UGC Center for Excellence in Nano Applications, Panjab University, Chandigarh 160 014, India UGC-Centre of Excellence in Applications of Nanomaterials, Nanoparticles & Nanocomposites (Biomedical Sciences), Panjab University, Chandigarh 160 014, India bsbhoop@pu.ac.in bsbhoop@yahoo.com.
authors.forename: Bhupinder
authors.initials: B
authors.lastname: Singh
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D000959:Antihypertensive Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000191:economics / Q000379:methods; D056148:Chromatography, Reverse-Phase / Q000191:economics / Q000379:methods*; D004355:Drug Stability; D057230:Limit of Detection; D000068557:Olmesartan Medoxomil / Q000032:analysis*; D015203:Reproducibility of Results
chemical_list: D000097:Acetonitriles; D000959:Antihypertensive Agents; D000068557:Olmesartan Medoxomil; C032159:acetonitrile