title: Solid-phase extraction and HPLC analysis of methylparaben and propylparaben in a concentrated antibiotic suspension.
abstract: An accurate and precise solid-phase extraction coupled with high performance liquid chromatography (SPE/HPLC) method developed for the quantification of antimicrobial preservatives (methylparaben and propylparaben) in oxytetracycline injectable suspension is described in this article. The SPE technique was necessary to quantify the preservatives since the high concentration of the drug and excipients was masking low levels of preservatives, making quantification difficult. This developed HPLC method was stability-indicating and found to be linear between 1.3 to 2.4 mg/mL for methylparaben and 0.15 to 0.27 mg/mL for propylparaben in this concentrated antibiotic suspension formulation. The extraction recoveries were 98.8-101.6%. System precision and sample extraction precision (RSD) were less than 1%.
authors.affiliation: Pharmaceutical Research and Development, BioPharma Solutions, Baxter Healthcare Corporation, Round Lake, Illinois 60073, USA. christine_rebbeck@baxter.com
authors.forename: Christine
authors.initials: C
authors.lastname: Rebbeck
authors.forename: Richard
authors.initials: R
authors.lastname: Hammond
authors.forename: Joseph
authors.initials: J
authors.lastname: Wong
authors.forename: Lakshmy
authors.initials: L
authors.lastname: Nair
authors.forename: Neervalur
authors.initials: N
authors.lastname: Raghavan
authors.forename: Doug
authors.initials: D
authors.lastname: Hepler
authors.forename: William
authors.initials: W
authors.lastname: Campbell
authors.forename: Randy
authors.initials: R
authors.lastname: Lynn
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D007273:Injections, Intramuscular; D010118:Oxytetracycline / Q000008:administration & dosage / Q000737:chemistry*; D010226:Parabens / Q000008:administration & dosage / Q000737:chemistry*; D011310:Preservatives, Pharmaceutical / Q000737:chemistry*; D013535:Suspensions; D013678:Technology, Pharmaceutical
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D010226:Parabens; D011310:Preservatives, Pharmaceutical; D013535:Suspensions; C015358:methylparaben; D010118:Oxytetracycline; C006068:propylparaben