title: Determination of total polyvinylpyrrolidone (PVP) in ophthalmic solutions by size exclusion chromatography with ultraviolet-visible detection.
abstract: A straightforward size exclusion chromatography (SEC) method was developed and validated for the determination of total polivinylpyrrolidone (PVP) in ophthalmic solutions using the unusual combination of size exclusion chromatography (SEC), ultraviolet-visible detection and quantitation of an analyte peak that elutes in the total exclusion volume of the column. Samples of opthalmic solutions are diluted with water and injected onto a TSKgel G1000PW, 7.5 mm i.d. × 30 cm, 12 μm column at 50°C, with 80:20 0.1M sodium acetate-methanol mobile phase and UV detection at 220 nm. Validation was successful for a stability indicating pharmaceutical method, with parameters including specificity, accuracy, linearity, and precision within typical pharmaceutical acceptance criteria. A stress study with acid, base, peroxide, heat, and light indicates that there is no interference from drug, product, or excipients.
authors.affiliation: Global R&D Operations, Analytical Development, Johnson & Johnson Group of Consumer Companies, Morris Plains, NJ 07950, USA.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Tavlarakis
authors.forename: John J
authors.initials: JJ
authors.lastname: Urban
authors.forename: Nicholas
authors.initials: N
authors.lastname: Snow
mesh_terms: D002850:Chromatography, Gel / Q000379:methods*; D016014:Linear Models; D009883:Ophthalmic Solutions / Q000737:chemistry*; D011205:Povidone / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet
chemical_list: D009883:Ophthalmic Solutions; D011205:Povidone