title: Analysis of polyhexamethylene biguanide in multipurpose contact lens solutions.
abstract: The objective of this study was to establish a reasonably simple and reliable method to measure very low concentrations of polyhexamethylene biguanide (PHMB) in multipurpose contact lens solutions (MPSs). By using a weak cation exchange solid phase extraction cartridge to extract the PHMB from MPS, followed by HPLC analysis using an evaporative light scattering detector, low levels (0.1 ppm) of PHMB were detected. Application of this method to a series of off-the-shelf MPS with PHMB as the active ingredient demonstrated these solutions contain 1 ppm. The contact lens solution with hydrogen peroxide as the active ingredient gave no peak where the PHMB peak eluted. The Polyquad contact lens solution generated a peak close to the retention time of PHMB. Recovery of PHMB from fortified hydrogen peroxide contact lens solution was good at 0.25 ppm and above; 105% with a RSD of 17% or less. The repeatability of the HPLC system ranged from 4 to 11% RSD; the reproducibility of the entire method was less than 17.5% RSD. Storage and stability studies indicated that storage of MPS with PHMB for chemical analysis are not temperature dependent, but are affected by the composition of the container in which the contact lens solution is stored.
authors.affiliation: US Food and Drug Administration, Center for Devices and Radiological Health, OSEL/DB, Silver Spring, MD 20993, USA. anne.lucas@fda.hhs.gov
authors.forename: Anne D
authors.initials: AD
authors.lastname: Lucas
authors.forename: Edward A
authors.initials: EA
authors.lastname: Gordon
authors.forename: Melvin E
authors.initials: ME
authors.lastname: Stratmeyer
mesh_terms: D001645:Biguanides / Q000032:analysis* / Q000737:chemistry / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018639:Contact Lens Solutions / Q000737:chemistry*; D004202:Disinfectants / Q000032:analysis / Q000737:chemistry / Q000302:isolation & purification; D004355:Drug Stability; D004356:Drug Storage; D006861:Hydrogen Peroxide / Q000737:chemistry; D009883:Ophthalmic Solutions / Q000737:chemistry; D015203:Reproducibility of Results; D052616:Solid Phase Extraction / Q000379:methods*; D013696:Temperature
chemical_list: D001645:Biguanides; D018639:Contact Lens Solutions; D004202:Disinfectants; D009883:Ophthalmic Solutions; C031233:polihexanide; D006861:Hydrogen Peroxide